Clearance Summary
TOP GUN received FDA 510(k) clearance under submission number K933742, sponsored by Bio-Medical Devices, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1994-04-07.
- Submission: K933742
- Applicant / Sponsor: Bio-Medical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5475
- Decision date: 1994-04-07
Classification & Regulation
This clearance is catalogued under FDA product code FQH and 21 CFR 880.5475, within the General Hospital review panel as a Class II device.