FDA 510(k) Application Details - K090141

Device Classification Name Dressing, Wound, Drug

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510(K) Number K090141
Device Name Dressing, Wound, Drug
Applicant B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN, PA 18109-9341 US
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Contact LISA GIAQUINTO
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 01/21/2009
Decision Date 03/17/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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