FDA WARNING_LETTER - Sandstone Medical Technologiess, LLC - April 18, 2008

FDA WARNING_LETTER for Sandstone Medical Technologiess, LLC on April 18, 2008. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sandstone Medical Technologiess, LLC on April 18, 2008. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 878.4810

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

21 CFR 1040.10

21 U.S.C. 352(t)(2)

21 CFR 1000-1010

21 CFR 1000

21 CFR 1002.10

21 CFR 820.25(b)

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

21 CFR 820.100(a)

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Record Information

Company

Sandstone Medical Technologiess, LLC

Inspection Date

April 18, 2008

Product Type

Devices

Office

New Orleans District Office

People

Tyler Thornburg (H.)

ID: 8d0dec63-c94e-4a54-bd03-8847b8b50f8f

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