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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 K213400
Device Name Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry
Applicant
Rb Health (Us)
399 Interpace Pkwy.
Parsippany,  NJ  07054
Applicant Contact Lisa Burns
Correspondent
Rb Health (Us)
399 Interpace Pkwy.
Parsippany,  NJ  07054
Correspondent Contact Lisa Burns
Regulation Number884.5300
Classification Product Code
NUC  
Date Received10/18/2021
Decision Date 03/01/2022
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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