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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 K222068
Device Name Durex Penck III Regular
Applicant
RB Health (US) LLC
399 Interpace Parkway
Parsippany,  NJ  07054
Applicant Contact Kyle Prince
Correspondent
RB Health (US) LLC
399 Interpace Parkway
Parsippany,  NJ  07054
Correspondent Contact Kyle Prince
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/14/2022
Decision Date 10/12/2022
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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