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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory Equipment, Cardiopulmonary Bypass
510(k) Number K990512
Device Name STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS
Applicant
Stoeckert Instrumente
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA JM NOLTE
Correspondent
Stoeckert Instrumente
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA JM NOLTE
Regulation Number870.4200
Classification Product Code
KRI  
Date Received02/18/1999
Decision Date 11/23/1999
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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