Clearance Summary
PHARMA-PLAST NEEDLE received FDA 510(k) clearance under submission number K852442, sponsored by Pharma-Plast USA, 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 1985-09-20.
- Submission: K852442
- Applicant / Sponsor: Pharma-Plast USA, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1985-09-20
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.