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FDA 510(k)

SKORE (Colors & Flavors), SKORE (Colors)

K-Number: K202403 · 2021-04-15

ApplicantTtk Healthcare Limited
Decision Date2021-04-15
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SKORE (Colors & Flavors), SKORE (Colors) is a medical device manufactured by Ttk Healthcare Limited. It received FDA 510(k) clearance on 2021-04-15 under approval number K202403. 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 (Colors & Flavors), SKORE (Colors)?

SKORE (Colors & Flavors), SKORE (Colors) is a medical device that received FDA 510(k) clearance on 2021-04-15. It is manufactured by Ttk Healthcare Limited. The 510(k) number is K202403.

When was SKORE (Colors & Flavors), SKORE (Colors) approved by the FDA?

SKORE (Colors & Flavors), SKORE (Colors) received FDA 510(k) clearance on 2021-04-15, under approval number K202403.

What company makes SKORE (Colors & Flavors), SKORE (Colors)?

SKORE (Colors & Flavors), SKORE (Colors) is manufactured by Ttk Healthcare Limited.

What is the FDA product code for SKORE (Colors & Flavors), SKORE (Colors)?

The FDA product code for SKORE (Colors & Flavors), SKORE (Colors) is HIS.

Other Devices by Ttk Healthcare Limited

K213547SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla 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

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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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