FDA 510(k) Application Details - K062796

Device Classification Name Lubricant, Patient, Vaginal, Latex Compatible

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510(K) Number K062796
Device Name Lubricant, Patient, Vaginal, Latex Compatible
Applicant PERSONAL PRODUCTS CO.
199 GRANDVIEW RD.
SKILLMAN, NJ 08558 US
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Contact NADER FOTOUHI
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Regulation Number 884.5300

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Classification Product Code NUC
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Date Received 09/19/2006
Decision Date 12/08/2006
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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