FDA WARNING_LETTER - UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) - December 02, 2010

FDA WARNING_LETTER for UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) on December 02, 2010. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) on December 02, 2010. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 803.18(d)(3)

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

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

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

21 CFR 820.198(a)

21 CFR 807.81(b)

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Record Information

Company

UROMATRIX Medical Systems (A Pos-T-Vac Medical Company)

Inspection Date

December 2, 2010

Product Type

Devices

Office

Department of Health and Human Services

People

ID: 6c01fe6d-4bc3-419b-aa32-2432dd3f2f67

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