Clearance Summary
PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 received FDA 510(k) clearance under submission number K992091, sponsored by Bio-Plexus, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1999-09-09.
- Submission: K992091
- Applicant / Sponsor: Bio-Plexus, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1999-09-09
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.