Clearance Summary
IDENTI-LOOPS received FDA 510(k) clearance under submission number K780720, sponsored by Berkeley Bio-Medical, 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 1978-10-17.
- Submission: K780720
- Applicant / Sponsor: Berkeley Bio-Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1978-10-17
Classification & Regulation
This clearance is catalogued under FDA product code GAD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.