FDA WARNING_LETTER - Hemcon Medical Technologies, Inc. - December 18, 2013

FDA WARNING_LETTER for Hemcon Medical Technologies, Inc. on December 18, 2013. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Hemcon Medical Technologies, Inc. on December 18, 2013. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

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

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

21 CFR 807.81(a)(3)(ii)

21 CFR 807.81(b)

21 U.S.C. 352(o)

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Record Information

Company

Hemcon Medical Technologies, Inc.

Inspection Date

December 18, 2013

Product Type

Devices

Office

Seattle District Office

People

Miriam R. Burbach

ID: 49bc0dd9-a13e-48d2-b286-59b258dcb109

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