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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 K213547
Device Name SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla
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 Received11/08/2021
Decision Date 12/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No