FDA 510(k) Application Details - K041224

Device Classification Name Drape, Surgical

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510(K) Number K041224
Device Name Drape, Surgical
Applicant FOOTHILLS INDUSTRIES, INC.
172 LUKIN ST.
MARION, NC 28752 US
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Contact JOY SHUFORD
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 05/10/2004
Decision Date 02/03/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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