Clearance Summary
STAND, SURG. INSTRUMENT & DRESSING received FDA 510(k) clearance under submission number K821921, sponsored by Emerson-Sack-Warner Corp.. 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 1982-07-30.
- Submission: K821921
- Applicant / Sponsor: Emerson-Sack-Warner Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1982-07-30
Classification & Regulation
This clearance is catalogued under FDA product code FSH and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.