FDA 510(k) Application Details - K072247

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K072247
Device Name Needle, Hypodermic, Single Lumen
Applicant B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN, PA 18109-9341 US
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Contact CHRISTINE FORD
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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 08/13/2007
Decision Date 11/08/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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