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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K971086
Device Name RADIAL AND FEMORAL ARTERY CATHETER
Applicant
B. Braun Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact MARK S ALSBERGE
Correspondent
B. Braun Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact MARK S ALSBERGE
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/25/1997
Decision Date 12/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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