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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K955485
Device Name BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS
Applicant
B. Braun Medical, Inc.
13000 Hwy. 55
Plymouth,  MN  55441 -3813
Applicant Contact BARBARA ATZENHOEFER
Correspondent
B. Braun Medical, Inc.
13000 Hwy. 55
Plymouth,  MN  55441 -3813
Correspondent Contact BARBARA ATZENHOEFER
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/01/1995
Decision Date 02/23/1996
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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