Kendall Argyle 2 Fr Double Lumen Neonatal/Pediatric Picc, Model 43304

• • Terminated Z-0932-05 FDA Unclassified (pre-2012) ·initiated 27 Apr 2005

  Holes in thermoformed tray compromising the sterility of the product.

510(k) Number

K042461 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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