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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 K930057
Device Name ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET
Original Applicant
B. BRAUN MEDICAL, INC.
13000 hwy. 55
plymouth,  MN  55441 -3813
Original Contact bruce d henke
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/06/1993
Decision Date 08/06/1993
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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