Clearance Summary
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators received FDA 510(k) clearance under submission number K153540, sponsored by Safe Secure Packaging 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 2016-08-04.
- Submission: K153540
- Applicant / Sponsor: Safe Secure Packaging Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2016-08-04
Classification & Regulation
This clearance is catalogued under FDA product code FRG and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.