Clearance Summary
DURABLUE STERILIZATION (AMSCO V-PRO) WRAP received FDA 510(k) clearance under submission number K112918, sponsored by Cardinal Health200, LLC. 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 2012-01-20.
- Submission: K112918
- Applicant / Sponsor: Cardinal Health200, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2012-01-20
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.