510(k) K990086 ยท KGN Wound Dressing With Animal-Derived Material(S)
HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
| Applicant | Integra Lifesciences Corp., Plainsboro NJ, US |
| Decision | Substantially Equivalent, Mar 31, 1999 |
| Received | Jan 11, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990086
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.