510(k) K894268

C.A.B. RING by Medi-Sharp, Inc. — Product Code MAB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1989
Date Received
June 22, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Cardiopulmonary Bypass (Vein Marker)
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type