Clearance Summary
CK 6000 SERIES, TOWELS received FDA 510(k) clearance under submission number K864697, sponsored by Currie Medical Specialties, 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 1986-12-18.
- Submission: K864697
- Applicant / Sponsor: Currie Medical Specialties, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1986-12-18
Classification & Regulation
This clearance is catalogued under FDA product code KKX and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.