FDA WARNING_LETTER - WAVi Co. - March 29, 2023

FDA WARNING_LETTER for WAVi Co. on March 29, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for WAVi Co. on March 29, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

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

21 CFR 820.184(d)

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

21 CFR 820

21 CFR 807.81(a)(1)

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

21 CFR 820.75(a)

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Record Information

Company

WAVi Co.

Inspection Date

March 29, 2023

Product Type

Devices

Office

Division of Medical Device and Radiological Health Operations East

People

ID: f1078981-a77d-4d0e-a2e2-6536c8105988

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