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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K893683
Device Name SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
Applicant
3M COMPANY
6200 JACKSON RD.
P.O. BOX 1247
ANN ARBOR,  MI  48106
Applicant Contact JAMES BALUN
Correspondent
3M COMPANY
6200 JACKSON RD.
P.O. BOX 1247
ANN ARBOR,  MI  48106
Correspondent Contact JAMES BALUN
Regulation Number870.4290
Classification Product Code
DTL  
Date Received05/16/1989
Decision Date 08/03/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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