AMERIGEL OINTMENT
FDA 510(k) clearance K970133 · decided 1997-04-14
Clearance details
- K-number
- K970133
- Device name
- AMERIGEL OINTMENT
- Applicant
- Amerx Health Care Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1997-01-15
- Decision date
- 1997-04-14
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- MGQ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. recall (Z-1797-2015) | Amerx Health Care Corp. | 2015-06-12 |