Clearance Summary
COHORT BONE BRUSH received FDA 510(k) clearance under submission number K942108, sponsored by Advanced Med/Surg, 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 1994-10-11.
- Submission: K942108
- Applicant / Sponsor: Advanced Med/Surg, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1994-10-11
Classification & Regulation
This clearance is catalogued under FDA product code HWE and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.