FDA WARNING_LETTER - Erchonia Corporation - November 24, 2009

FDA WARNING_LETTER for Erchonia Corporation on November 24, 2009. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Erchonia Corporation on November 24, 2009. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.25

21 CFR 820.250(b)

21 CFR 820.30(i)

21 U.S.C. 321(h)

21 CFR 820.100(a)(1)

21 CFR 820.80(b)

21 U.S.C. 360(k)

21 CFR 820.90(a)

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

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Record Information

Company

Erchonia Corporation

Inspection Date

November 24, 2009

Product Type

Devices

Office

Dallas District Office

People

ID: 176472e2-0a97-4fdf-b284-b71296037cf7

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