FDA WARNING_LETTER - AkivaMed Inc. - July 08, 2020

FDA WARNING_LETTER for AkivaMed Inc. on July 08, 2020. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for AkivaMed Inc. on July 08, 2020. 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. 351(f)(1)(B)

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360bbb-3

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

21 U.S.C. 352(o)

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Record Information

Company

AkivaMed Inc.

Inspection Date

July 8, 2020

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy Stenzel

ID: 52cdf197-0ff8-4977-bf17-32180acc4779

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