Clearance Summary
SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC received FDA 510(k) clearance under submission number K070117, sponsored by Dolomite Biotech Sdn Bhd. 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 2007-08-06.
- Submission: K070117
- Applicant / Sponsor: Dolomite Biotech Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2007-08-06
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.