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FDA 510(k)

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

K-Number: K213547 · 2021-12-23

ApplicantTtk Healthcare Limited
Decision Date2021-12-23
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla is a medical device manufactured by Ttk Healthcare Limited. It received FDA 510(k) clearance on 2021-12-23 under approval number K213547. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla?

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla is a medical device that received FDA 510(k) clearance on 2021-12-23. It is manufactured by Ttk Healthcare Limited. The 510(k) number is K213547.

When was SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla approved by the FDA?

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla received FDA 510(k) clearance on 2021-12-23, under approval number K213547.

What company makes SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla?

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla is manufactured by Ttk Healthcare Limited.

What is the FDA product code for SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla?

The FDA product code for SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla is HIS.

Other Devices by Ttk Healthcare Limited

K202403SKORE (Colors & Flavors), SKORE (Colors) K230049SKORE 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

Related Devices (Code: HIS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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