Clearance Summary
SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM received FDA 510(k) clearance under submission number K112936, sponsored by Rexam Consummer Plastics Inc.D/B/A Rexam Pharma. 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 2012-01-20.
- Submission: K112936
- Applicant / Sponsor: Rexam Consummer Plastics Inc.D/B/A Rexam Pharma
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2012-01-20
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.