TOMAC STERILE DISP. LAP SPONGE— 510(k) K812554
Substantially EquivalentAmerican Convertors Div., American Pharmaseal
FDA 510(k) clearance K812554 for TOMAC STERILE DISP. LAP SPONGE, Substantially Equivalent on 1981-09-24. Applicant: American Convertors Div., American Pharmaseal.
Clearance details
- Applicant
- American Convertors Div., American Pharmaseal
- Product code
- Code GDY
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, 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.