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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 K070545
Device Name K-Y BRAND WARMING LIQUID
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 Received02/26/2007
Decision Date 03/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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