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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 K193450
Device Name Pre-Seed™ Fertility Lubricant
Applicant
Church & Dwight Co., Inc.
500 Charles Ewing Blvd.
Ewing,  NJ  08628
Applicant Contact Joelle Reinson
Correspondent
Church & Dwight Co., Inc.
500 Charles Ewing Blvd.
Ewing,  NJ  08628
Correspondent Contact Joelle Reinson
Regulation Number884.5300
Classification Product Code
PEB  
Date Received12/13/2019
Decision Date 07/23/2020
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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