Clearance Summary
TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML) received FDA 510(k) clearance under submission number K022278, sponsored by Taiject Medical Device Co., Ltd.. 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 2002-09-12.
- Submission: K022278
- Applicant / Sponsor: Taiject Medical Device Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2002-09-12
Classification & Regulation
This clearance is catalogued under FDA product code MEG and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.