Clearance Summary
POINT OF USE II SHARPS-A-GATOR received FDA 510(k) clearance under submission number K964387, sponsored by Graphic Controls Corp.. 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 1997-03-27.
- Submission: K964387
- Applicant / Sponsor: Graphic Controls Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1997-03-27
Classification & Regulation
This clearance is catalogued under FDA product code MMK and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.