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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Pump, Cardiopulmonary Bypass
510(k) Number K902845
Device Name GENTLE HEADER
Applicant
Enhanced Perfusion Systems, Inc.
P.O. Box 418
Grass Lake,  MI  49240
Applicant Contact WALT CARPENTER
Correspondent
Enhanced Perfusion Systems, Inc.
P.O. Box 418
Grass Lake,  MI  49240
Correspondent Contact WALT CARPENTER
Regulation Number870.4390
Classification Product Code
DWE  
Date Received06/28/1990
Decision Date 12/03/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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