510(k) K812244

INTERFACE PRE BYPASS PRIME FILTER #90 by Medical, Inc. — Product Code KRJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1981
Date Received
August 11, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Prebypass, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4280
Review Panel
CV
Submission Type