Clearance Summary
SPONGE COUNTER received FDA 510(k) clearance under submission number K926225, sponsored by American Medical Manufacturer, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1993-03-05.
- Submission: K926225
- Applicant / Sponsor: American Medical Manufacturer, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4950
- Decision date: 1993-03-05
Classification & Regulation
This clearance is catalogued under FDA product code FWZ and 21 CFR 878.4950, within the General, Plastic Surgery review panel as a Class I device.