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
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