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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K072247
Device Name STERICAN HYPODERMIC NEEDLES
Applicant
B.Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Applicant Contact CHRISTINE FORD
Correspondent
B.Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Correspondent Contact CHRISTINE FORD
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/13/2007
Decision Date 11/08/2007
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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