The following data is part of a premarket notification filed by Belcher Pharmaceuticals, Inc. with the FDA for Mucotrol Concentrated Oral Gel Wafer.
| Device ID | K042400 |
| 510k Number | K042400 |
| Device Name: | MUCOTROL CONCENTRATED ORAL GEL WAFER |
| Classification | Dressing, Wound, Drug |
| Applicant | BELCHER PHARMACEUTICALS, INC. 12393 BELCHER ROAD SUITE 420 Largo, FL 33773 |
| Contact | Kotha Sekharam |
| Correspondent | Kotha Sekharam BELCHER PHARMACEUTICALS, INC. 12393 BELCHER ROAD SUITE 420 Largo, FL 33773 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-03 |
| Decision Date | 2004-11-24 |
| Summary: | summary |