FDA WARNING_LETTER - Z-Medica, LLC - November 03, 2009

FDA WARNING_LETTER for Z-Medica, LLC on November 03, 2009. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Z-Medica, LLC on November 03, 2009. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.75(b)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.20(c)

21 CFR 820.198(c)

21 CFR 820.75(a)

21 U.S.C. 351(h)

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Record Information

Company

Z-Medica, LLC

Inspection Date

November 3, 2009

Product Type

Devices

Office

New England District Office

People

John R. Marzilli

ID: 4300f3e5-c280-4045-b085-1a97f1e53feb

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