510(k) K042400 ยท OLR Oral Wound Dressing
MUCOTROL CONCENTRATED ORAL GEL WAFER
| Applicant | Belcher Pharmaceuticals, Inc., Largo FL, US |
| Decision | Substantially Equivalent, Nov 24, 2004 |
| Received | Sep 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042400
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2007 | Belcher Pharmaceuticals Inc. Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle. Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.