FDA 510(k) Application Details - K032666

Device Classification Name Drape, Surgical

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510(K) Number K032666
Device Name Drape, Surgical
Applicant MEDLINE INDUSTRIES, INC.
1170 S. NORTHPOINT BLVD.
WAUKEGAN, IL 60085 US
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Contact LARA SIMMONS
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 08/28/2003
Decision Date 03/16/2005
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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