510(k) K080497 ยท FRO Dressing, Wound, Drug
DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)
| Applicant | Derma Sciences Canada, Inc., Toronto, Orntario, CA |
| Decision | Substantially Equivalent, Jun 27, 2008 |
| Received | Feb 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Acetate Petrolatum Emulsion Sterile Model Number: 77042.
b. Open, Classified |
GER | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.