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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K062796
Device Name K-Y BRAND INTRIGUE
Applicant
PERSONAL PRODUCTS CO.
199 GRANDVIEW RD.
SKILLMAN,  NJ  08558
Applicant Contact NADER FOTOUHI
Correspondent
PERSONAL PRODUCTS CO.
199 GRANDVIEW RD.
SKILLMAN,  NJ  08558
Correspondent Contact NADER FOTOUHI
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/19/2006
Decision Date 12/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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