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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 K760388
Device Name CATHETER, VEIN (VENOFIX)
Applicant
B. BRAUN INSTRUMENTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
B. BRAUN INSTRUMENTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1200
Classification Product Code
DQO  
Date Received08/05/1976
Decision Date 11/02/1976
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
Recalls CDRH Recalls
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