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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 K072421
Device Name K-Y BRAND YOURS+MINE
Applicant
Mcneil-Ppc, Inc.
199 Grandview Rd.
Skillman,  NJ  08558
Applicant Contact NADER FOTOUHI
Correspondent
Mcneil-Ppc, Inc.
199 Grandview Rd.
Skillman,  NJ  08558
Correspondent Contact NADER FOTOUHI
Regulation Number884.5300
Classification Product Code
NUC  
Date Received08/28/2007
Decision Date 03/06/2008
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 Yes
Predetermined Change
Control Plan Authorized		 No
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