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510(k) K113073

IO-TOME DEVICE by Baxano, Inc. — Product Code HAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2012
Date Received
October 17, 2011
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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  • 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)
  • K062711 — ULTRA LOW PROFILE RONGEUR (March 7, 2007)

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