510(k) K183645 ยท FRO Dressing, Wound, Drug
Silver High Performance Dressing
| Applicant | Advanced Medical Solutions, Ltd., Winsford, GB |
| Decision | Substantially Equivalent, May 29, 2019 |
| Received | Dec 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183645
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4" (10/BX) Catalog #87400.
b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WND GELLING FIBER HIABSRB AG 4X4.7 Open, Classified |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.