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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 K193032
Device Name KY Grosz Liquid
Applicant
RB Health (US) LLC
399 Interpace Parkway
Parsippany,  NJ  07054
Applicant Contact Elizabeth Viguerie
Correspondent
RB Health (US) LLC
399 Interpace Parkway
Parsippany,  NJ  07054
Correspondent Contact Elizabeth Viguerie
Regulation Number884.5300
Classification Product Code
NUC  
Date Received10/31/2019
Decision Date 04/20/2020
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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