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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K834025
Device Name SARNS CARDIOPLEGIA CANNULA Y
Applicant
3M Health Care, Sarns
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
3M Health Care, Sarns
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/22/1983
Decision Date 01/03/1984
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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