FDA WARNING_LETTER - Atom Medical Corporation - September 20, 2013

FDA WARNING_LETTER for Atom Medical Corporation on September 20, 2013. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Atom Medical Corporation on September 20, 2013. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.20(c)(1)

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

21 CFR 820.50(a)(1)

21 CFR 803.50(a)

21 CFR 820.86

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(a)

21 CFR 803

21 U.S.C. 351(h)

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Record Information

Company

Atom Medical Corporation

Inspection Date

September 20, 2013

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 39ba6293-d8e4-47aa-a2c9-832d6603ae7c

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