Clearance Summary
CAMLOC SYRINGE BIOPSY KIT received FDA 510(k) clearance under submission number K801304, sponsored by Johannah Medical Services, 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 1980-06-17.
- Submission: K801304
- Applicant / Sponsor: Johannah Medical Services, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1980-06-17
Classification & Regulation
This clearance is catalogued under FDA product code GEE and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.