510(k) K935189 ยท KGN Wound Dressing With Animal-Derived Material(S)
E-Z DERM BIOSYNTHETIC WOUND DRESSING
| Applicant | Brennen Medical, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent for Some Indications, Jul 11, 1994 |
| Received | Oct 26, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935189
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2019 | Molnlycke Health Care, Inc EZ Derm Porcine Xenograft, labeled as the following:
a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03;
b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03;
c. Terminated |
KGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.