Clearance Summary
CODMAN SUCTION PATTIE received FDA 510(k) clearance under submission number K901937, 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 1990-07-16.
- Submission: K901937
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1990-07-16
Classification & Regulation
This clearance is catalogued under FDA product code GCX and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.