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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 K230049
Device Name SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT
Applicant
Ttk Healthcare Limited
12, K P Natham Rd., Thiruvandar Koil
Puducherry,  IN 605102
Applicant Contact Daniel J S
Correspondent
Ttk Healthcare Limited
6, Cathedral Rd.
Chennai,  IN 600086
Correspondent Contact Daniel J S
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/06/2023
Decision Date 09/07/2023
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
Predetermined Change
Control Plan Authorized		 No
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