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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 K200672
Device Name Durex Penck Standard, Durex Penck XL
Applicant
Rb Health (Us), LLC
399 Interpace Pkwy.
Parsippany,  NJ  07054
Applicant Contact Kyle Prince
Correspondent
Rb Health (Us), LLC
399 Interpace Pkwy.
Parsippany,  NJ  07054
Correspondent Contact Kyle Prince
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/13/2020
Decision Date 11/06/2020
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
Predetermined Change
Control Plan Authorized		 No
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