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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K073396
Device Name ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG
Applicant
B.Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Applicant Contact REBECCA STOLARICK
Correspondent
B.Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Correspondent Contact REBECCA STOLARICK
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/03/2007
Decision Date 08/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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