Clearance Summary
SYRIGENE PRE-FILLED SYRINGE received FDA 510(k) clearance under submission number K935669, sponsored by Regulatory & Marketing Services, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1994-02-18.
- Submission: K935669
- Applicant / Sponsor: Regulatory & Marketing Services, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class III
- Regulation citation: 21 CFR 888.3320
- Decision date: 1994-02-18
Classification & Regulation
This clearance is catalogued under FDA product code JDL and 21 CFR 888.3320, within the Orthopedic review panel as a Class III device.