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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 K210294
Device Name One Touch Spiral Condom
Applicant
Thai Nippon Rubber Industry Public Company Limited.
789/139 Pinthong Industrial Estate Nongkham
Sriracha,  TH 20230
Applicant Contact Ryosuke Takamiya
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/02/2021
Decision Date 09/23/2021
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 No
Predetermined Change
Control Plan Authorized		 No
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