FDA 510(k) Application Details - K102861

Device Classification Name Drape, Surgical

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510(K) Number K102861
Device Name Drape, Surgical
Applicant A PLUS INTERNATIONAL, INC.
5138 EUCALYPTUS AVE.,
CHINO, CA 91710 US
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Contact SOLOMON CHEN
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 09/30/2010
Decision Date 01/13/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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