FDA 510(k) Application Details - K032065

Device Classification Name Cover, Barrier, Protective

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510(K) Number K032065
Device Name Cover, Barrier, Protective
Applicant MEDLINE INDUSTRIES, INC.
1170 S. NORTHPOINT BLVD.
WAUKEGAN, IL 60085 US
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Contact LARA N SIMMONS
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Regulation Number 878.4370

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Classification Product Code MMP
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Date Received 07/03/2003
Decision Date 09/22/2003
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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