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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 K171213
Device Name One Touch Condom with Benzocaine
Thai Nippon Rubber Industry Public Company Limited
1 Charoenrat Road, Thungwatdon, Sathon
bangkok,  TH 10120
Applicant Contact pisut chanwatarungkull (pete)
Thai Nippon Rubber Industry Public Company Limited
33 Golden Eagle Lane
littleton,  CO  80127
Correspondent Contact kevin walls
Regulation Number884.5300
Classification Product Code
Date Received04/25/2017
Decision Date 01/12/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes