Clearance Summary
ODONTIT AUTOGENOUS BONE COLLECTION DEVICE received FDA 510(k) clearance under submission number K971036, sponsored by Interpore Intl.. 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 1997-06-03.
- Submission: K971036
- Applicant / Sponsor: Interpore Intl.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4680
- Decision date: 1997-06-03
Classification & Regulation
This clearance is catalogued under FDA product code GCY and 21 CFR 878.4680, within the General, Plastic Surgery review panel as a Class I device.