Clearance Summary
DISPOSABLE SYRINGE WITH NEEDLE received FDA 510(k) clearance under submission number K870191, sponsored by Can-Am Surgical Corp.. 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 1987-04-16.
- Submission: K870191
- Applicant / Sponsor: Can-Am Surgical Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1987-04-16
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.