FDA WARNING_LETTER - Meditherm Inc. - Unknown Date

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

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Record Summary

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

Violation Codes

21 U.S.C. 360(a)

21 U.S.C. 352(a)

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

21 U.S.C. 360(i)(1)(A)

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 352(0)

21 CFR 807.97

21 CFR 807.81(a)(3)(ii)

21 CFR 801.6

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Record Information

Company

Meditherm Inc.

Inspection Date

Unknown Date

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Steven D. Silverman (President)

ID: 1c605ee0-a0d0-4f3a-b31a-7df3a25f6843

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