FDA 510(k) Application Details - K031362

Device Classification Name Drape, Surgical

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510(K) Number K031362
Device Name Drape, Surgical
Applicant LAC MAC, LTD.
10907 WAREHAM COURT
AUSTIN, TX 78739 US
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Contact JEFFREY O STULL
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 02/20/2003
Decision Date 05/30/2003
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 N
Expedited Review



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