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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 K942391
Device Name BRAUN MANIFOLD
Applicant
B.Braun Medical, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018 -0027
Applicant Contact MARK S ALSBERGE
Correspondent
B.Braun Medical, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018 -0027
Correspondent Contact MARK S ALSBERGE
Regulation Number870.4290
Classification Product Code
DTL  
Date Received05/19/1994
Decision Date 06/21/1995
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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