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510(k) K902845

GENTLE HEADER by Enhanced Perfusion Systems, Inc. — Product Code DWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1990
Date Received
June 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Pump, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4390
Review Panel
CV
Submission Type

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