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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 the device name listed in this FDA 510(k) record. The listed applicant is Tuttnauer U.S.A Co, Ltd.. It received FDA 510(k) clearance on 2023-11-27 under 510(k) 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. The listed applicant is Tuttnauer U.S.A Co, Ltd.. The 510(k) number is K232658.

When did T-Top 10 & T-Top T-Top 11 receive FDA 510(k) clearance?

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

Who is the listed applicant for T-Top 10 & T-Top T-Top 11?

The FDA 510(k) record lists Tuttnauer U.S.A Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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