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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K931743
Device Name BURRON CARDIOVASCULAR ANGESTAT(TM)
Original Applicant
B. BRAUN MEDICAL, INC.
13000 hwy. 55
plymouth,  MN  55441 3813
Original Contact steve huntley
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/07/1993
Decision Date 11/02/1993
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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