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FDA 510(k)

10PL

K-Number: K220794 · 2022-11-10

ApplicantTentech Co. , Ltd.
Decision Date2022-11-10
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

10PL is a medical device manufactured by Tentech Co. , Ltd.. It received FDA 510(k) clearance on 2022-11-10 under approval number K220794. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 10PL?

10PL is a medical device that received FDA 510(k) clearance on 2022-11-10. It is manufactured by Tentech Co. , Ltd.. The 510(k) number is K220794.

When was 10PL approved by the FDA?

10PL received FDA 510(k) clearance on 2022-11-10, under approval number K220794.

What company makes 10PL?

10PL is manufactured by Tentech Co. , Ltd..

What is the FDA product code for 10PL?

The FDA product code for 10PL is ONF.

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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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