Clearance Summary
THE REEL THING received FDA 510(k) clearance under submission number K940156, sponsored by Bio-Medical Devices, 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 1994-06-07.
- Submission: K940156
- Applicant / Sponsor: Bio-Medical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1994-06-07
Classification & Regulation
This clearance is catalogued under FDA product code GBX and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.