FDA WARNING_LETTER - Ondamed GmBH - Unknown Date

FDA WARNING_LETTER for Ondamed GmBH on Unknown Date. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Ondamed GmBH on Unknown Date. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 882.5050

21 CFR 882.9

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

21 U.S.C. 351(f)(1)(8)

21 CFR 807.81(b)

21 U.S.C. 352(o)

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Record Information

Company

Ondamed GmBH

Inspection Date

Unknown Date

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: e0cb1c52-f6a6-4926-bf3e-cd1d9f8e8a8a

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