FDA 510(k) Application Details - K014239

Device Classification Name Cover, Barrier, Protective

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510(K) Number K014239
Device Name Cover, Barrier, Protective
Applicant INTERNATIONAL MEDSURG CONNECTION
P.O. BOX 848
GRAYSLAKE, IL 60030 US
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Contact MICHELE H VOVOLKA
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Regulation Number 878.4370

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Classification Product Code MMP
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Date Received 12/26/2001
Decision Date 02/19/2002
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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