US Device Listing when not the 510(k) owner

J1980b

Starting to get Involved
Good Morning,

Is it allowed to register a device (on FURLS) for which the company is not the named Applicant?
Assuming we have a supply contract with company X. and Company X is the original applicant for the 510(k). My company (Company Y) wishes to receive the manufactured devices unlabelled, and label them in line with our Customers Brand names, to ensure Company X does not know who our Customers are. Can we then register the devices on the Brand names using the K number from Company X?

I think the answer is no, but I can't pinpont why this wouldn't work, nor which regulations it would contravene

KR
JB
 

monoj mon

Trusted Information Resource
One possible way is, if you fit into the definition of 'Repackager-Relabaler' and your customers are only 'domestic distributor'. Then while listing the device, you can make the 'brand name' confidential and it won't be displayed to anyone publicly. By this way, in my opinion, the Company X won't able to figure out who are the actual distributor.
 

Asia78

Involved In Discussions
The MDR doesn't put all resistable surgical instruments into class Or, it specifies which functions those should have to be considered class Ir. It also explains that if they are active (connected to an electrical device) they will also be class IIa. So you need to look at the intended purpose of your device and at the definition written in the mdr
 
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