FDA 510(k) Application Details - K080796

Device Classification Name Drape, Surgical

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510(K) Number K080796
Device Name Drape, Surgical
Applicant SRI/SURGICAL EXPRESS
P.O. BOX 92493
AUSTIN, TX 78709 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 03/20/2008
Decision Date 11/17/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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