Clearance Summary
MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP received FDA 510(k) clearance under submission number K896589, sponsored by Optik. 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 1989-12-27.
- Submission: K896589
- Applicant / Sponsor: Optik
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1989-12-27
Classification & Regulation
This clearance is catalogued under FDA product code LRZ and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.