Clearance Summary
CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER received FDA 510(k) clearance under submission number K921347, sponsored by Medi-Flex Hospital Products, 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 1993-01-08.
- Submission: K921347
- Applicant / Sponsor: Medi-Flex Hospital Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5075
- Decision date: 1993-01-08
Classification & Regulation
This clearance is catalogued under FDA product code MCY and 21 CFR 880.5075, within the General Hospital review panel as a Class II device.