510(k) K092086
- Device
- AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027
- Applicant
- AMERX HEALTH CARE CORP.
- 510(k) number
- K092086
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-07-30
- Date received
- 2009-07-09
- 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
- ART W SIMONETTI, LPN
- Address
- 1300 S. Highland Ave. Clearwater FL US 33756 33756
FDA Registration Numbers#
- 1646434
- 1648579
- 3006784948
Source Documents#
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| 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 |
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Legacy Summary#
summary
FDA Review#
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