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FDA 510(k)

T-Top 10 & T-Top T-Top 11

K-Number: K232658 · 2023-11-27

ApplicantTuttnauer U.S.A Co, Ltd.
Decision Date2023-11-27
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

T-Top 10 & T-Top T-Top 11 is a medical device manufactured by Tuttnauer U.S.A Co, Ltd.. It received FDA 510(k) clearance on 2023-11-27 under approval number K232658. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-Top 10 & T-Top T-Top 11?

T-Top 10 & T-Top T-Top 11 is a medical device that received FDA 510(k) clearance on 2023-11-27. It is manufactured by Tuttnauer U.S.A Co, Ltd.. The 510(k) number is K232658.

When was T-Top 10 & T-Top T-Top 11 approved by the FDA?

T-Top 10 & T-Top T-Top 11 received FDA 510(k) clearance on 2023-11-27, under approval number K232658.

What company makes T-Top 10 & T-Top T-Top 11?

T-Top 10 & T-Top T-Top 11 is manufactured by Tuttnauer U.S.A Co, Ltd..

What is the FDA product code for T-Top 10 & T-Top T-Top 11?

The FDA product code for T-Top 10 & T-Top T-Top 11 is FLE.

Related Devices (Code: FLE)

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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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