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510(k) K941492

PRESSURE RELIEF VALVE by Circulatory Technology, Inc. — Product Code MNJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 26, 1994
Date Received: March 28, 1994
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Valve, Pressure Relief, Cardiopulmonary Bypass
Device Class: Class II
Regulation Number: 870.4400
Review Panel: CV
Submission Type

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