FDA WARNING_LETTER - Cochlear Bone Anchored Solutions AB - May 17, 2007

FDA WARNING_LETTER for Cochlear Bone Anchored Solutions AB on May 17, 2007. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Cochlear Bone Anchored Solutions AB on May 17, 2007. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 352(t)(2)

21 CFR 820.25(b)

21 CFR 803.3

21 CFR 803.50(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.90(b)(2)

21 U.S.C. 381(a)

21 CFR 803

21 CFR 820.30(f)

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Record Information

Company

Cochlear Bone Anchored Solutions AB

Inspection Date

May 17, 2007

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 25866f55-d66e-4674-b7c6-42dc3c5fa715

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