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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, gamete, fertilization, and embryo compatible
510(k) Number K190872
Device Name BioGenesis Fertility Lubricant
Applicant
Good Clean Love, Inc.
207 W. 5th Avenue
eugene,  OR  97401
Applicant Contact wendy strgar
Correspondent
Amin Talati Upadhye, LLP
100 South Wacker Drive, Suite 2000
chicago,  IL  60606
Correspondent Contact abhishek gurnani
Regulation Number884.5300
Classification Product Code
PEB  
Date Received04/03/2019
Decision Date 11/07/2019
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
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