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Threads Tagged with 510(k)
	Discussion Thread Title / Thread Starter	Last Post or Poll Vote	Replies	Views	Forum
	Testing data for Special 510k and contact person Jennifer27 started this discussion on 5th March 2013	14th May 2013 08:04 PM by Jennifer27	4	287	Other US Medical Device Regulation Topics
	IEC 62304 and FDA Level of Concern ( 1 2) LiamD started this discussion on 25th March 2013	12th May 2013 05:03 AM by sagai	8	643	IEC 62304 - Medical Device Software Life Cycle Processes
	FDA 510(k) Submission Tests - Posterior Cervical Spinestem dogbural started this discussion on 9th May 2013	10th May 2013 02:14 AM by Stijloor	1	127	US Medical Devices (21 CFR part 820)
	Who is the Specification Developer in this case? ( 1 2) Mikeee started this discussion on 6th May 2013	8th May 2013 08:48 PM by Ronen E	10	315	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
	Can one 510K be used on multiple products? sherley13 started this discussion on 7th May 2013	7th May 2013 04:32 PM by MIREGMGR	1	178	US Food and Drug Administration (FDA)
	510k Submission - Where to describe firmware and firmware design documentation? tallu started this discussion on 30th April 2013	3rd May 2013 05:05 AM by Pads38	4	271	US Medical Devices (21 CFR part 820)
	What are FDA expectations regarding Standards referenced in the 510(k)? mscottf started this discussion on 30th April 2013	1st May 2013 08:26 AM by Ajit Basrur	3	219	US Food and Drug Administration (FDA)
	Do we need to submit Special 510K for a Blood Glucose System? paullarn started this discussion on 13th April 2013	29th April 2013 08:01 PM by Ronen E	4	307	US Medical Devices (21 CFR part 820)
	In 510k application do we submit documents showing compliance with 21CFRPart820 regmeddevices started this discussion on 11th June 2011	29th April 2013 07:52 PM by Ronen E	7	882	Other US Medical Device Regulation Topics
	Verify GB/T 16886 is the same as ISO 10993 bbrown579 started this discussion on 4th April 2013	18th April 2013 08:54 AM by bbrown579	3	281	US Food and Drug Administration (FDA)
	IEC 60601-1 , 3rd edition and the FDA Nissim Shaked started this discussion on 15th April 2013	17th April 2013 10:06 AM by Ronen E	2	338	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
	Deciding when to submit a Special 510(k) ( 1 2) Bobbulb started this discussion on 27th June 2011	10th April 2013 10:25 AM by qagirl	10	1,386	US Food and Drug Administration (FDA)
	IEC 60601-1 testing for device with its own 2V battery power supply necessary? messer started this discussion on 3rd April 2013	3rd April 2013 10:18 AM by SteveK	1	242	US Medical Devices (21 CFR part 820)
	What is the difference between Traditional and Abbreviated 510(K) application ? lisakrotha started this discussion on 28th March 2013	28th March 2013 04:02 AM by Ajit Basrur	1	221	Other Medical Device and Orthopedic Related Topics
	510(k) Submission for a huge, changing complex Medical Device System wangyang started this discussion on 18th November 2012	26th March 2013 01:31 AM by Ronen E	4	461	Other US Medical Device Regulation Topics
	Changing Company Ownership of Medical Devices Burgmeister started this discussion on 21st March 2013	21st March 2013 05:26 PM by Ronen E	1	190	US Medical Devices (21 CFR part 820)
	Referencing Standards in Engineering and Regulatory Documents mscottf started this discussion on 11th March 2013	11th March 2013 09:14 AM by pkost	1	253	Other ISO and International Standards and European Regulations
	510k Submission - Class II Software communicates with a Non-Classified Device tebusse started this discussion on 7th February 2013	8th March 2013 11:21 AM by yodon	5	315	US Medical Devices (21 CFR part 820)
	Class II Software Device 510k V&V (Verification and Validation) Criteria and Results tebusse started this discussion on 28th February 2013	7th March 2013 10:41 PM by Michael Malis	4	330	US Medical Devices (21 CFR part 820)
	New 510k for change to Intended Use - Prescription to OTC Bonebuilder started this discussion on 7th March 2013	7th March 2013 05:53 PM by Bonebuilder	2	190	US Medical Devices (21 CFR part 820)

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