Clearance Summary
3M(TM) SURGICAL SLIPPER, 9660 SERIES received FDA 510(k) clearance under submission number K946162, sponsored by Wahl Clipper 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 1995-01-24.
- Submission: K946162
- Applicant / Sponsor: Wahl Clipper Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1995-01-24
Classification & Regulation
This clearance is catalogued under FDA product code LWK and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.