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510(k) K081742

BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 by Baxano, Inc. — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2008
Date Received
June 19, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type

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  • K092729 — BAXANO NEURO CHECK DEVICE (October 2, 2009)
  • K080494 — BAXANO ULTRA LOW PROFILE RONGEUR (March 4, 2008)
  • K063231 — MICROBLADE SHAVER AND ACCESSORIES (April 16, 2007)
  • K062711 — ULTRA LOW PROFILE RONGEUR (March 7, 2007)

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