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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 K152646
Device Name SYLK PERSONAL LUBRICANT
Applicant
Toro Management, LLC Dba Sylk
7272 E. Indian School Rd.
Suite 540
Scottsdale,  AZ  85251
Applicant Contact MARIESSA MAHFOUZ
Correspondent
Qpc Services
P.O. Box 818
Ocean Shores,  WA  98569
Correspondent Contact JEFF MORGAN
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/16/2015
Decision Date 03/11/2016
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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