FDA 510(k) Application Details - K102666

Device Classification Name Drape, Surgical

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510(K) Number K102666
Device Name Drape, Surgical
Applicant KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
BLDG 300, #1093
ROSWELL, GA 30076-2199 US
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Contact MARCIA JOHNSON
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 09/15/2010
Decision Date 11/09/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party Y
Expedited Review



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