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FDA 510(k) Application Details - K962320
Device Classification Name
Heat-Exchanger, Cardiopulmonary Bypass
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510(K) Number
K962320
Device Name
Heat-Exchanger, Cardiopulmonary Bypass
Applicant
STOECKERT INSTRUMENTE
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact
DIANE MINEAR
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Regulation Number
870.4240
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Classification Product Code
DTR
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More FDA Info for this Product Code
Date Received
06/17/1996
Decision Date
01/10/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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