Valve, Standard Model Pudenze Flushing

• • Terminated Z-1984-2012 FDA Class II ·initiated 4 Apr 2012

  The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the device. The incorrect label reads: "Model: 12 mm-Medium Pressure" instead of "Model: 16 mm-Low Pressure".

510(k) Number

K760501 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• 2 Fr Kelman Chamber Maintainer

  Class II

  FDA 510(k) K792096 Active Cleared 16 Nov 1979

• Radovan Subcutaneous Tissue Expander

  Unclassified

  FDA 510(k) K771224 Active Cleared 11 Oct 1977

• Mishler 2 Chamb Flushing Valve, Anti-Syph

  Class II

  FDA 510(k) K760785 Active Cleared 1 Nov 1976

• Mishler 2 Chamb Flushing Valve, Stand

  Class II

  FDA 510(k) K760784 Active Cleared 1 Nov 1976

• T-Tube Drain, Round

  Class I

  FDA 510(k) K760778 Active Cleared 3 Nov 1976

• Subcutaneous Tissue Expander

  Unclassified

  FDA 510(k) K790842 Active Cleared 3 Aug 1979

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