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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K960674
Device Name CONTRAST INJECTION LINES
Applicant
B.Braun Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact MARK S ALSBERGE
Correspondent
B.Braun Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact MARK S ALSBERGE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received02/20/1996
Decision Date 09/19/1996
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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