FDA 510(k) Application Details - K040164

Device Classification Name Lubricant, Patient, Vaginal, Latex Compatible

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510(K) Number K040164
Device Name Lubricant, Patient, Vaginal, Latex Compatible
Applicant PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC
199 GRANDVIEW RD.
SKILLMAN, NJ 08558-9418 US
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Contact MARYLOU P CARLSON
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Regulation Number 884.5300

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Classification Product Code NUC
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Date Received 01/26/2004
Decision Date 04/05/2004
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

FDA Source Information for K040164


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