Clearance Summary
AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE received FDA 510(k) clearance under submission number K031394, sponsored by American Syringe Company. 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 2003-07-25.
- Submission: K031394
- Applicant / Sponsor: American Syringe Company
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2003-07-25
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.