Playboy 3 Contour 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 Playboy 3 Contour Condom.

Pre-market Notification Details

Device IDK211450
510k NumberK211450
Device Name:Playboy 3 Contour Condom
ClassificationCondom
Applicant Thai Nippon Rubber Industry Public Company Limited 789/139 Pinthong Industrial Estate Nongkham Sriracha,  TH 20230
ContactTossaporn Nilkhamhang
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 Received2021-05-10
Decision Date2021-09-30

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