510(k) K060804 ยท FRO Dressing, Wound, Drug
COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING
| Applicant | Covalon Technologies, Ltd., Waxhaw NC, US |
| Decision | Substantially Equivalent, Apr 18, 2006 |
| Received | Mar 24, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060804
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylcellulose (CMC) / Ethylenediamine-tetraacetic Acid (EDTA) 4 X 4 Inch 10 Count Mod Open, Classified |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.