510(k) K971095 ยท EFQ Gauze/Sponge, Internal
OPPORTUNITY SUTURE REMOVAL KIT
| Applicant | Opportunity, Inc., Highland Park IL, US |
| Decision | Substantially Equivalent for Some Indications, Sep 16, 1997 |
| Received | Mar 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971095
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.