FDA WARNING_LETTER - Pioneer Surgical Technology - April 22, 2010

FDA WARNING_LETTER for Pioneer Surgical Technology on April 22, 2010. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Pioneer Surgical Technology on April 22, 2010. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 812.40

21 CFR 54

21 U.S.C. 321(h)

21 CFR 50.25(a)

21 CFR 812.7(d)

21 CFR 812.45

21 CFR 50.25(b)

21 CFR 812.43(c)(5)

21 CFR 812.140(b)(2)

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Record Information

Company

Pioneer Surgical Technology

Inspection Date

April 22, 2010

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: dbeeeb13-5342-4dc5-bf74-3918c6cf45f3

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