Barrier Hip Pack W/ Fabric 450

• • Terminated Z-1137-03 FDA Unclassified (pre-2012) ·initiated 14 Jul 2003 ·on shared 510(k) K780282

  pouch may tear which could result in contamination of sterile field

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K780282 ↗

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Edge Protector, Barrier

  Class II

  FDA 510(k) K790306 Active Cleared 22 Feb 1979

• Barrier Pediatric/Incise Drape 450

  Class II

  FDA 510(k) K780839 Active Cleared 14 Aug 1978

• Barrier General Surgery Pack

  Class II

  FDA 510(k) K760807 Active Cleared 3 Nov 1976

• Barrier Antimicrobial Incise Drape

  Class II

  FDA 510(k) K820543 Active Cleared 22 Jul 1982

• Purge Line Unit

  Class II

  FDA 510(k) K790804 Active Cleared 25 May 1979

• Sterile Surgical Scrub Brush

  Class I

  FDA 510(k) K874653 Active Cleared 30 Dec 1987

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