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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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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