AMERIGEL OINTMENT— 510(k) K970133
Substantially Equivalent for Some IndicationsAmerx Health Care Corp.
FDA 510(k) clearance K970133 for AMERIGEL OINTMENT, Substantially Equivalent for Some Indications on 1997-04-14. Applicant: Amerx Health Care Corp..
Clearance details
- Applicant
- Amerx Health Care Corp.
- Product code
- Code MGQ
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Clearwater, FL, US
Adverse events under product code MGQ
product code MGQ- Death
- 16
- Total
- 16
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.