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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
510(k) Number K955152
Device Name STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER
Applicant
Stoeckert Instrumente
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
Stoeckert Instrumente
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number870.4340
Classification Product Code
DTW  
Subsequent Product Codes
DTQ   KRL  
Date Received11/13/1995
Decision Date 02/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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