FDA WARNING_LETTER - C Change Surgical, LLC - March 20, 2008

FDA WARNING_LETTER for C Change Surgical, LLC on March 20, 2008. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for C Change Surgical, LLC on March 20, 2008. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 820.80(d)

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

21 CFR 820.25(b)

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

21 CFR 820

21 CFR 820.72(a)

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

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Record Information

Company

C Change Surgical, LLC

Inspection Date

March 20, 2008

Product Type

Devices

Office

Atlanta District Office

People

Mary H. Woleske

ID: c4e2b3ba-d30b-451e-a46d-ccc78e55133f

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