Bd K-4000 Microkeratome System

• • Terminated Z-0066-2008 FDA Unclassified (pre-2012) ·initiated 9 Aug 2007

  Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea

510(k) Number

K023092 ↗

FDA Product Code

HMY

Device Class

Class I

Regulation

21 CFR Part 886.4370

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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