FDA 510(k) Application Details - K091863

Device Classification Name Dressing, Wound, Drug

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510(K) Number K091863
Device Name Dressing, Wound, Drug
Applicant AUBREY, INC.
5930 SEA LION PLACE
CARLSBAD, CA 92010 US
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Contact AUBREY WOODROF
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 06/23/2009
Decision Date 01/21/2010
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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