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510(k) K080494

BAXANO ULTRA LOW PROFILE RONGEUR by Baxano, Inc. — Product Code HAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2008
Date Received
February 22, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur, Manual
Device Class
Class II
Regulation Number
882.4840
Review Panel
NE
Submission Type

Other clearances by Baxano, Inc.

  • K113073 — IO-TOME DEVICE (July 27, 2012)
  • K113533 — NEURO CHECK DEVICE WITH IO-FLEX WIRE (April 11, 2012)
  • K110696 — NEURO CHECK DEVICE WITH IO-FLEX WIRE (July 7, 2011)
  • K102594 — IO-FLEX CATHETER (January 19, 2011)
  • K100958 — MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES (July 23, 2010)
  • K092729 — BAXANO NEURO CHECK DEVICE (October 2, 2009)
  • K081742 — BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 (September 17, 2008)
  • K063231 — MICROBLADE SHAVER AND ACCESSORIES (April 16, 2007)
  • K062711 — ULTRA LOW PROFILE RONGEUR (March 7, 2007)

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