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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 -9418
Applicant Contact MARYLOU (PANICO) CARLSON
Correspondent
PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC
199 GRANDVIEW RD.
SKILLMAN,  NJ  08558 -9418
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
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