Clearance Summary
WILSON-COOK BRONCHOSCOPE BIOPSY FORCEPS received FDA 510(k) clearance under submission number K901348, sponsored by Wilson-Cook Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-10-09.
- Submission: K901348
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4465
- Decision date: 1990-10-09
Classification & Regulation
This clearance is catalogued under FDA product code EGQ and 21 CFR 872.4465, within the Dental review panel as a Class II device.