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510(k) K143564

Visual-ICE Cryoablation System, Software Revision 1.3.1 by Galil Medical, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2015
Date Received
December 16, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

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  • K140584 — ICEROD CX CRYOABLATION NEEDLE (March 31, 2014)
  • K123865 — VISUAL-ICE CRYOABLATION SYSTEM (February 6, 2013)

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