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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 K212000
Device Name Medley
Applicant
Good Clean Love, Inc.
207 W 5th Ave.
Eugene,  OR  97401
Applicant Contact Wendy Strgar
Correspondent
Amin Talati Wasserman, Llp
100 S Wacker Dr. Suite 2000
Chicago,  IL  60606
Correspondent Contact Abhishek Gurnani
Regulation Number884.5300
Classification Product Code
NUC  
Date Received06/28/2021
Decision Date 11/18/2021
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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