Clearance Summary
Sterilization Pouch/Roll Made with Tyvek received FDA 510(k) clearance under submission number K180672, sponsored by Sigma Medical Supplies Corporation. 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 2018-06-06.
- Submission: K180672
- Applicant / Sponsor: Sigma Medical Supplies Corporation
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2018-06-06
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.