Clearance Summary
KEEP-ACCOUNT SHARPS DISPOSAL SYSTEM received FDA 510(k) clearance under submission number K810134, sponsored by Info-Chem. 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 1981-02-26.
- Submission: K810134
- Applicant / Sponsor: Info-Chem
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1981-02-26
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.