Clearance Summary
SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION received FDA 510(k) clearance under submission number K141664, sponsored by Rexam Healthcare. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2014-10-02.
- Submission: K141664
- Applicant / Sponsor: Rexam Healthcare
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2014-10-02
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.