Clearance Summary
Jewel Precision Reusable Rigid Sterilization Container System received FDA 510(k) clearance under submission number K162600, sponsored by Jewel Precision Sheet Metal & Machine, Inc.. 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 2016-12-09.
- Submission: K162600
- Applicant / Sponsor: Jewel Precision Sheet Metal & Machine, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2016-12-09
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.