FDA 510(k) Application Details - K051347

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K051347
Device Name Polymer Patient Examination Glove
Applicant KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL, GA 30076 US
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Contact RICHARD V WOLFE
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 05/24/2005
Decision Date 06/07/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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