Clearance Summary
OLSEN #770 DISPOSABLE HOLSTER received FDA 510(k) clearance under submission number K820158, sponsored by Olsen Electro-Surgical Instruments, 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 1982-02-05.
- Submission: K820158
- Applicant / Sponsor: Olsen Electro-Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1982-02-05
Classification & Regulation
This clearance is catalogued under FDA product code KDC and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.