PROTEC X-RAY DETECTABLE GAUZE SPONGE— 510(k) K955322
Substantially EquivalentDerivados DE Gasa, S.A. DE C.V.
FDA 510(k) clearance K955322 for PROTEC X-RAY DETECTABLE GAUZE SPONGE, Substantially Equivalent on 1995-12-19. Applicant: Derivados DE Gasa, S.A. DE C.V..
Clearance details
- Applicant
- Derivados DE Gasa, S.A. DE C.V.
- Product code
- Code GDY
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Harobor, FL, US
Adverse events under product code GDY
product code GDY- Malfunction
- 764
- Total
- 764
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.