Clearance Summary
BIODYNE INSTRUMENT WIPES received FDA 510(k) clearance under submission number K900691, sponsored by Bio-Dyne, 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 1990-03-08.
- Submission: K900691
- Applicant / Sponsor: Bio-Dyne, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1990-03-08
Classification & Regulation
This clearance is catalogued under FDA product code GEC and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.