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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 K945396
Device Name FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET
Original Applicant
B. BRAUN MEDICAL, INC.
13000 hwy. 55
plymouth,  MN  55441 3813
Original Contact barbara atzenhoefer
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/03/1994
Decision Date 03/13/1995
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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