SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

Condom

TTK Healthcare Limited

The following data is part of a premarket notification filed by Ttk Healthcare Limited with the FDA for Skore Smooth Condoms - Skore Colors & Flavors, Skore Smooth Condoms - Skore Vanilla.

Pre-market Notification Details

Device IDK213547
510k NumberK213547
Device Name:SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla
ClassificationCondom
Applicant TTK Healthcare Limited 12, K P Natham Road, Thiruvandar Koil, Puducherry,  IN 605102
ContactDaniel J S
CorrespondentDaniel J S
TTK Healthcare Limited 6, Cathedral Road Chennai,  IN 600086
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-08
Decision Date2021-12-23

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.