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Tracking, Soft Tissue, Intraoperative

FDA product code OEW · 3 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.4560
Review panel
SU
Implant
No
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2007-12-20 – 2011-02-09

For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

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