FDA WARNING_LETTER - Nexera Medical, Inc. - July 31, 2012

FDA WARNING_LETTER for Nexera Medical, Inc. on July 31, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Nexera Medical, Inc. on July 31, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 803.20(c)(1)

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

21 CFR 803.3

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.100(b)

21 CFR 803

21 CFR 820.50

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Record Information

Company

Nexera Medical, Inc.

Inspection Date

July 31, 2012

Product Type

Devices

Office

Department of Health and Human Services

People

Emma R. Singleton (District Director)

ID: 988c4a01-dbb4-4250-8130-692b7ee1d05d

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