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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 K181844
Device Name One Touch
Applicant
Thai Nippon Rubber Industry Public Company Ltd
1 Charoenrat Road, Thungwatdon, Sathon
bangkok,  TH 10120
Applicant Contact pisut chanwatarungkull
Correspondent
KUPS International
8516 Burning Tree Road,
bethesda,  MD  20817
Correspondent Contact prabhat garg
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/11/2018
Decision Date 04/15/2019
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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