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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K213647
Device Name Durex Patronus Wide
Applicant
Rb Health (Us), LLC
399 Interpace Pkwy.
Parsippany,  NJ  07054 -1133
Applicant Contact Kaitlyn Chan
Correspondent
Rb Health (Us), LLC
399 Interpace Pkwy.
Parsippany,  NJ  07054 -1133
Correspondent Contact Kaitlyn Chan
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/19/2021
Decision Date 02/17/2022
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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