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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 K220489
Device Name Durex Patronus CloseFit, Durex Patronus Regular
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 Received02/22/2022
Decision Date 11/07/2022
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
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