FDA WARNING_LETTER - Neurolumen LLC - December 13, 2013

FDA WARNING_LETTER for Neurolumen LLC on December 13, 2013. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Neurolumen LLC on December 13, 2013. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

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

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

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 CFR 820.90(a)

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

21 CFR 820.198(a)

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Record Information

Company

Neurolumen LLC

Inspection Date

December 13, 2013

Product Type

Devices

Office

Dallas District Office

People

Reynaldo R. Rodriguez (District Director)

ID: 489d5717-f6d9-49ec-99aa-09b244cb783f

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