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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 K021492
Device Name K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT
Applicant
Personal Products Co., Div. of Mcneil Ppc, Inc.
199 Grandview Rd.
Skillman,  NJ  08558
Applicant Contact MARYLOU PANICO
Correspondent
Personal Products Co., Div. of Mcneil Ppc, Inc.
199 Grandview Rd.
Skillman,  NJ  08558
Correspondent Contact MARYLOU PANICO
Regulation Number884.5300
Classification Product Code
NUC  
Date Received05/09/2002
Decision Date 08/07/2002
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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