Clearance Summary
CARDIO-PAK LAPAROTOMY PACK received FDA 510(k) clearance under submission number K923233, sponsored by Cardio-Med-Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1993-03-20.
- Submission: K923233
- Applicant / Sponsor: Cardio-Med-Associates, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5070
- Decision date: 1993-03-20
Classification & Regulation
This clearance is catalogued under FDA product code FZH and 21 CFR 878.5070, within the General, Plastic Surgery review panel as a Class II device.