FDA 510(k) Application Details - K082869

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K082869
Device Name Dressing, Wound, Collagen
Applicant AUBREY, INC.
5930 SEA LION PLACE
CARLSBAD, CA 92010 US
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Contact STEPHEN MOSS
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 09/29/2008
Decision Date 02/06/2009
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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