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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 K021488
Device Name SURECAN SAFETY HUBER NEEDLE INFUSION SETS
Applicant
B.Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Applicant Contact SHERI L MASGNUNG
Correspondent
B.Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Correspondent Contact SHERI L MASGNUNG
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
LJT  
Date Received05/08/2002
Decision Date 07/08/2002
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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