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510(k) K062711

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2007
Date Received
September 11, 2006
Clearance Type
Traditional
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.

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  • 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)
  • K080494 — BAXANO ULTRA LOW PROFILE RONGEUR (March 4, 2008)
  • K063231 — MICROBLADE SHAVER AND ACCESSORIES (April 16, 2007)

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