One Touch Spiral Condom

Condom

Thai Nippon Rubber Industry Public Company Limited

The following data is part of a premarket notification filed by Thai Nippon Rubber Industry Public Company Limited with the FDA for One Touch Spiral Condom.

Pre-market Notification Details

Device IDK210294
510k NumberK210294
Device Name:One Touch Spiral Condom
ClassificationCondom
Applicant Thai Nippon Rubber Industry Public Company Limited 789/139 Pinthong Industrial Estate Nongkham Sriracha,  TH 20230
ContactRyosuke Takamiya
CorrespondentKevin Walls
Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton,  CO  80127
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-02
Decision Date2021-09-23

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.