510(k) K042400
- Device
- MUCOTROL CONCENTRATED ORAL GEL WAFER
- Applicant
- BELCHER PHARMACEUTICALS, INC.
- 510(k) number
- K042400
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-11-24
- Date received
- 2004-09-03
- Regulation
- 510(k) Premarket Notification
- Classification name
- Dressing, Wound, Drug
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KOTHA SEKHARAM
- Address
- 12393 Belcher Rd. Suite 420 Largo FL US 33773 33773
FDA Registration Numbers#
- 8043396
- 3016611551
- 3003311293
- 3019867040
- 3010143501
- 1450662
- 3007735241
- 2032542
- 3013576473
- 3010864832
- 3016505723
- 3016096134
- 2244725
- 3004050854
- 3011276993
- 3004985762
- 1424263
- 3004146122
- 3005488444
- 3006619672
- 3029906643
- 9611959
- 3015528146
- 2135339
- 3012263097
- 1646434
- 3006497550
- 2518467
- 3005488671
- 3004087544
- 2938386
Source Documents#
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | 2026-05-13 |
| K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026-04-07 |
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | 2026-03-25 |
| K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | 2026-03-13 |
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | 2026-01-23 |
| K250890 | SBC1 Cream | Sioxmed, LLC | 2026-01-12 |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | 2026-01-08 |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2026-01-05 |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2025-12-19 |
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | Huizhou Foryou Medical Devices Co., Ltd. | 2025-11-19 |
| K250115 | Hemastyl(™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | 2025-10-14 |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | 2025-10-10 |
| K243166 | Dermalage | Infection Elimination Solutions, LLC | 2025-08-27 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases