FDA WARNING_LETTER - Cutera Inc. - July 09, 2012

FDA WARNING_LETTER for Cutera Inc. on July 09, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Cutera Inc. on July 09, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

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

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

21 CFR 807.81(a)(3)(i)

21 CFR 807.81(b)

21 U.S.C. 352(o)

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Record Information

Company

Cutera Inc.

Inspection Date

July 9, 2012

Product Type

Devices

Office

Department of Health and Human Services

People

Steven D. Silverman (President)

ID: 2f6ac340-f4b9-4b6e-a6de-83f5c877fdd7

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