SKORE (Colors & Flavors), SKORE (Colors)

Condom

TTK Healthcare Limited

The following data is part of a premarket notification filed by Ttk Healthcare Limited with the FDA for Skore (colors & Flavors), Skore (colors).

Pre-market Notification Details

Device IDK202403
510k NumberK202403
Device Name:SKORE (Colors & Flavors), SKORE (Colors)
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-21
Decision Date2021-04-15

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