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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
Applicant
B.Braun Medical, Inc.
13000 Hwy. 55
Plymouth,  MN  55441
Applicant Contact BARBARA ATZENHOEFER
Correspondent
B.Braun Medical, Inc.
13000 Hwy. 55
Plymouth,  MN  55441
Correspondent Contact BARBARA ATZENHOEFER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/03/1994
Decision Date 03/13/1995
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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