FDA 510(k) Application Details - K031750

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K031750
Device Name Vinyl 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 LYZ
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Date Received 06/05/2003
Decision Date 10/24/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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