DeviceClearance

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine +2 more— 510(k) K230049

Substantially Equivalent

Ttk Healthcare Limited

FDA 510(k) clearance K230049 for SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine +2 more, Substantially Equivalent on 2023-09-07. Applicant: Ttk Healthcare Limited. Device class: 2.

Clearance details

Device name as filed
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
Product code
Code HIS
Device class
Class 2
Regulation
21 CFR 884.5300
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Puducherry, IN
Download summary PDFView on FDA.gov ↗

Recent devices under product code HIS

view all

More clearances from Ttk Healthcare Limited

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.