FDA 510(k) Application Details - K052870

Device Classification Name Sealant, Microbial

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510(K) Number K052870
Device Name Sealant, Microbial
Applicant KIMBERLY-CLARK CORP.
5353 WAYZATA BLVD., SUITE 505
MINNEAPOLIS, MN 55416-1334 US
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Contact TIERNEY NORSTED
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Regulation Number 878.4370

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Classification Product Code NZP
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Date Received 10/11/2005
Decision Date 09/29/2006
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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