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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom, synthetic
510(k) Number K182438
Device Name Synthetic Polyisoprene Lubricated Male Condom - 5 senses
Applicant
Sxwell Usa LLC
111 Wood Avenue South
Iselin,  NJ  08830
Applicant Contact Robert Mahler
Correspondent
Sxwell Usa LLC
111 Wood Avenue South
Iselin,  NJ  08830
Correspondent Contact Robert Mahler
Regulation Number884.5300
Classification Product Code
MOL  
Date Received09/07/2018
Decision Date 12/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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