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FDA 510(k) Application Details - K955152
Device Classification Name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
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510(K) Number
K955152
Device Name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Applicant
STOECKERT INSTRUMENTE
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact
ROSINA ROBINSON
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Regulation Number
870.4340
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Classification Product Code
DTW
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More FDA Info for this Product Code
Date Received
11/13/1995
Decision Date
02/22/1996
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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