510(k) K172010 ยท KGN Wound Dressing With Animal-Derived Material(S)
gel-e Bandage
| Applicant | Gel-E, Inc. (Formerly Remedium Technologies, Inc.), College Park MD, US |
| Decision | Substantially Equivalent, Dec 7, 2017 |
| Received | Jul 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172010
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.