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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 K031923
Device Name ULTRASITE VALVE
Applicant
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN,  PA  18109
Applicant Contact SHERI L MUSGNUNG
Correspondent
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN,  PA  18109
Correspondent Contact SHERI L MUSGNUNG
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/23/2003
Decision Date 08/11/2003
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
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