FDA 510(k) Application Details - K083234

Device Classification Name Drape, Surgical

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510(K) Number K083234
Device Name Drape, Surgical
Applicant KIMBERLY-CLARK CORP.
172 CONDUCTOR DRIVE
DAWSONVILLE, GA 30534 US
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Contact LISA PEACOCK
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 11/03/2008
Decision Date 03/25/2009
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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