FDA 510(k) Application Details - K120650

Device Classification Name Lubricant, Patient, Vaginal, Latex Compatible

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510(K) Number K120650
Device Name Lubricant, Patient, Vaginal, Latex Compatible
Applicant KIMBERLY-CLARK CORPORATION
1400 HOLCOMB BRIDGE RD.
ROSWELL, GA 30076 US
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Contact Swarna Mukund
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Regulation Number 884.5300

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Classification Product Code NUC
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Date Received 03/02/2012
Decision Date 07/11/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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