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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 K210208
Device Name Titan Condoms
Applicant
Titan Condoms, LLC
1950 Elkhorn Ct. Unit 210
San Mateo,  CA  94403
Applicant Contact Neville Muringayi
Correspondent
Medicsense USA
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact George Hattub
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/26/2021
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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