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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 K202403
Device Name SKORE (Colors & Flavors), SKORE (Colors)
TTK Healthcare Limited
12, K P Natham Road, Thiruvandar Koil,
Puducherry,  IN 605102
Applicant Contact Daniel J. S.
TTK Healthcare Limited
6, Cathedral Road
Chennai,  IN 600086
Correspondent Contact Daniel J. S.
Regulation Number884.5300
Classification Product Code
Date Received08/21/2020
Decision Date 04/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No