FDA WARNING_LETTER - Union Square Medical Imaging & Mammography - February 11, 2014

FDA WARNING_LETTER for Union Square Medical Imaging & Mammography on February 11, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Union Square Medical Imaging & Mammography on February 11, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 900.12(j)

42 U.S.C. 263b(h)

21 CFR 900.12(e)(6)

21 CFR 900.12(d)(2)

21 CFR 900.12(a)(1)(ii)(B)

21 CFR 900.12(a)(2)(iv)(A)

21 CFR 900.12(e)(2)

21 CFR 900.12(a)(2)(ii)(C)

21 CFR 900.1(a)(2)(iii)(E)

42 U.S.C. 263b(j)

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Record Information

Company

Union Square Medical Imaging & Mammography

Inspection Date

February 11, 2014

Product Type

Devices

Office

New York District Office

People

ID: 2393e1c8-2a7e-4369-9abb-09d7eba51dcb

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