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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 K183302
Device Name KY Banksy Aloe
Applicant
Rb Health (Us), LLC
399 Interpace Pkwy.
Parsippany,  NJ  07054
Applicant Contact Elizabeth Viguerie
Correspondent
Rb Health (Us), LLC
399 Interpace Pkwy.
Parsippany,  NJ  07054
Correspondent Contact Elizabeth Viguerie
Regulation Number884.5300
Classification Product Code
NUC  
Date Received11/27/2018
Decision Date 04/16/2019
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
Predetermined Change
Control Plan Authorized		 No
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