Selector Integra Ultrasonic Surgical Aspirator, Model Om 1530000M3

• • Terminated Z-0431-06 FDA Unclassified (pre-2012) ·initiated 28 Nov 2005

  Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. (2nd recall, same problem see Z-141-6)

• • Terminated Z-0141-06 FDA Unclassified (pre-2012) ·initiated 13 Sep 2005

  Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.

510(k) Number

K021989 ↗

FDA Product Code

LFL

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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• Licox Cmp Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1, CC1.SB Luicox Imc Introducer Kits-Im, IM2, IM3, II1 Licoximc Tempe

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• Selector Quantum Ultrasonic Aspirator System

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  FDA 510(k) K042277 Active Cleared 29 Sep 2004

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See all devices from Integra Neurosciences →