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510(k) K953821

BIOCOR 200 HARDSHELL VENOUS RESERVIOR by Minntech Corp. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1996
Date Received
August 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

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