Multiple owners for one listed device

C

cathykao

#1
Q1: Can one listed device (with a single listing number) have multiple (more than one) owners?
Q2: Can two listed devices with different "proprietary names" (with different
owners) share one cleared/approved premarket submission number (510(k), PMA, PDP, HDE, De Novo) if the two listed devices are actually with
identical design and technical characteristics?
 
Elsmar Forum Sponsor

pziemlewicz

Involved In Discussions
#2
Q1: No. Device Identification would be different for each owner. I'd expect two separate submissions, i.e. the first PMA and second 510(k), with a different sponsor for each.
Q2: Also no. The different names would require two different sets of labeling.
 
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