Budde-Halo Retractor

• • Terminated Z-0781-03 FDA Unclassified (pre-2012) ·initiated 26 Feb 2003

  The component was manufactured with an insufficient weld that could break during use.

510(k) Number

K830332 ↗

FDA Product Code

GZT

Device Class

Class II

Regulation

21 CFR Part 882.4800

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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