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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 K040340
Device Name K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT
Applicant
Personal Products Company, Div. of Mcneil-Ppc, Inc.
199 Grandview Rd.
Skillman,  NJ  08558
Applicant Contact MARYLOU (PANICO) CARLSON
Correspondent
Personal Products Company, Div. of Mcneil-Ppc, Inc.
199 Grandview Rd.
Skillman,  NJ  08558
Correspondent Contact MARYLOU (PANICO) CARLSON
Regulation Number884.5300
Classification Product Code
NUC  
Date Received02/11/2004
Decision Date 04/28/2004
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
Predetermined Change
Control Plan Authorized		 No
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