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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 K142726
Device Name O Glide Personal Lubricant
Applicant
Grafenberg Labs
755 Second Ave.
New York,  NY  10017
Applicant Contact Manny Frankl
Correspondent
Mjrac
1208-12 Rockford Rd.
Toronto,  CA M2R 3A2
Correspondent Contact Bosmat Friedman
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/23/2014
Decision Date 07/24/2015
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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