510(k) K123113 ยท FRO Dressing, Wound, Drug
L.A.M. IMP WOUND GEL
| Applicant | Glycobiosciences, Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Dec 11, 2012 |
| Received | Oct 3, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123113
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2014 | Wellspring Pharmaceutical Corporation IPM Wound Gel Rx Wound Dressing
IPM Wound Gel is indicated for the management of wound healing. Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.