Clearance Summary
DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950 received FDA 510(k) clearance under submission number K990371, sponsored by Post Medical, 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 1999-04-21.
- Submission: K990371
- Applicant / Sponsor: Post Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1999-04-21
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.