Finding specific 510k guidance for Keratoprosthesis (MLP)

RobertvanBoxtel

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Who can explain where to find the specific 510k guidance for keratoprosthesis?
And who can explain what this means (found under the regulation number 886.3400):
65 FR 17147, Mar. 31, 2000

Thanks already for your help!!

Robert
 
M

MIREGMGR

Who can explain where to find the specific 510k guidance for keratoprosthesis?

Simple. Search engines are your friend. Take the document title from the 886.3400 regulation page, paste it into the search box on the FDA Medical Devices page, click on the best-fit search result.

https://www.fda.gov/downloads/medic...onandguidance/guidancedocuments/ucm073787.pdf

And who can explain what this means (found under the regulation number 886.3400):
65 FR 17147, Mar. 31, 2000

That's the edition and date of the Federal Register, the US Government's daily official journal, in which 21CFR 886.3400 was most recently published/updated.
 
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