Clearance Summary
CODMAN STERILIZATION CONTAINERS received FDA 510(k) clearance under submission number K092437, sponsored by Codman & Shurtleff, 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 2010-03-25.
- Submission: K092437
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2010-03-25
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.