FDA WARNING_LETTER - Curewave Lasers LLC - September 05, 2019

FDA WARNING_LETTER for Curewave Lasers LLC on September 05, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Curewave Lasers LLC on September 05, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

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

21 CFR 1002.10

21 CFR 820.30(a)

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

21 CFR 1040.11(a)(1)

21 U.S.C. 321(h)

21 CFR 1002.13

21 U.S.C. 360oo(a)(4)

21 CFR 1010.3(a)

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Record Information

Company

Curewave Lasers LLC

Inspection Date

September 5, 2019

Product Type

Devices

Office

Office of Medical Device and Radiological Health Operations (Division 1)

People

ID: 73514a46-6266-49de-88c1-06da78465dac

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