FDA WARNING_LETTER - Power Medical Interventions Incorporation - May 21, 2008

FDA WARNING_LETTER for Power Medical Interventions Incorporation on May 21, 2008. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Power Medical Interventions Incorporation on May 21, 2008. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

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

21 CFR 803.18(b)(1)(i)

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(a)

21 CFR 820.198(c)

21 CFR 803

21 CFR 803.50(b)(3)

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Record Information

Company

Power Medical Interventions Incorporation

Inspection Date

May 21, 2008

Product Type

Devices

Office

Philadelphia District Office

People

Thomas D. Gardine (District District Director)

ID: d57cdf6b-77e8-4f6e-8a20-4e9e91438ca7

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