Clearance Summary
DISPOSABLE PLASTIC SYRINGES received FDA 510(k) clearance under submission number K851523, sponsored by Transcoject GmbH & Co. KG. 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 1985-07-24.
- Submission: K851523
- Applicant / Sponsor: Transcoject GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1985-07-24
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.