FDA WARNING_LETTER - RESET TECHNOLOGY CORPORATION - December 20, 2024

FDA WARNING_LETTER for RESET TECHNOLOGY CORPORATION on December 20, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for RESET TECHNOLOGY CORPORATION on December 20, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 801.40(a)(2)

21 U.S.C. 351

21 CFR 820.198

21 CFR 830.320(b)

21 CFR 820.25(b)

21 CFR 820.100(a)

21 CFR 820.70(c)

21 CFR 807.65(i)

21 U.S.C. 321(h)

21 CFR 820.90(b)(2)

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Record Information

Company

RESET TECHNOLOGY CORPORATION

Inspection Date

December 20, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: fb285b23-7137-4475-9314-6a129a0796ef

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