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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 K201186
Device Name KY Grosz Jelly
RB Health (US) LLC
399 Interpace Pkwy
Parsippany,  NJ  07054
Applicant Contact Elizabeth Viguerie
RB Health (US) LLC
399 Interpace Pkwy
Parsippany,  NJ  07054
Correspondent Contact Elizabeth Viguerie
Regulation Number884.5300
Classification Product Code
Date Received05/01/2020
Decision Date 07/30/2020
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
Recalls CDRH Recalls