Clearance Summary
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator received FDA 510(k) clearance under submission number K160595, sponsored by Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti. 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 2016-11-18.
- Submission: K160595
- Applicant / Sponsor: Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2016-11-18
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.