FDA WARNING_LETTER - Centurion Medical Products Corporation - August 20, 2019

FDA WARNING_LETTER for Centurion Medical Products Corporation on August 20, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Centurion Medical Products Corporation on August 20, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 801

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

21 CFR 820.50(a)(1)

21 CFR 820.30(a)

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

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 3.2(e)(2)

21 U.S.C. 360(k)

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Record Information

Company

Centurion Medical Products Corporation

Inspection Date

August 20, 2019

Product Type

Devices

Office

Division of Medical Device and Radiological Health Operations East

People

ID: ed608ec1-ce0c-4310-9cc8-91e6f774b2cb

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