L-F Coiled Extension Tubing

• • Terminated Z-1123-2012 FDA Not yet classified ·initiated 10 Feb 2012

  The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.

510(k) Number

K882329 ↗

FDA Product Code

DXT

Device Class

Class II

Regulation

21 CFR Part 870.1650

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K902761 Active Cleared 9 Oct 1990

• X-Ray Film, Convey or System

  Class II

  FDA 510(k) K760279 Active Cleared 13 Aug 1976

• Hydrajust IV Urological Table

  Class II

  FDA 510(k) K920742 Active Cleared 27 Apr 1992

• Neuro Vision Radiographic X-Ray System

  Class II

  FDA 510(k) K904146 Active Cleared 13 Dec 1990

• Uro-Flo

  Class II

  FDA 510(k) K945140 Active Cleared 8 Mar 1995

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