FDA 510(k) Application Details - K020827

Device Classification Name Lubricant, Patient, Vaginal, Latex Compatible

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510(K) Number K020827
Device Name Lubricant, Patient, Vaginal, Latex Compatible
Applicant PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC.
199 GRANDVIEW RD.
SKILLMAN, NJ 08558-9418 US
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Contact MARYLOU PANICO
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Regulation Number 884.5300

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Classification Product Code NUC
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Date Received 03/14/2002
Decision Date 06/12/2002
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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