510(k) K950850 ยท FRG Wrap, Sterilization
GENT-L-KARE LACERATION TRAYS
| Applicant | Premium Plastics, Inc., Chicago IL, US |
| Decision | Substantially Equivalent for Some Indications, Mar 14, 1995 |
| Received | Feb 24, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950850
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.