Clearance Summary
SURGICAL INSTRUMENT, DISPOSABLE received FDA 510(k) clearance under submission number K940684, sponsored by Her-Mar, 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 1994-03-14.
- Submission: K940684
- Applicant / Sponsor: Her-Mar, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1994-03-14
Classification & Regulation
This clearance is catalogued under FDA product code MDM and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.