FDA WARNING_LETTER - ikcon investments, inc - February 11, 2021

FDA WARNING_LETTER for ikcon investments, inc on February 11, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for ikcon investments, inc on February 11, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

21 U.S.C. 331(a)

21 U.S.C. 331(k)

21 U.S.C. 352(a)

21 U.S.C. 351(f)(1)(B)

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

21 CFR 807.39

21 U.S.C. 352(o)

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Record Information

Company

ikcon investments, inc

Inspection Date

February 11, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy Stenzel

ID: f9ec1ba7-b361-479c-be28-157c1f05ade3

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