AMERIGEL OINTMENT SATURATED WOUND DRESSING
FDA 510(k) clearance K971918 · decided 1997-08-12
Clearance details
- K-number
- K971918
- Device name
- AMERIGEL OINTMENT SATURATED WOUND DRESSING
- Applicant
- Amerx Health Care Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-23
- Decision date
- 1997-08-12
- Days to decision
- 81 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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