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510(k) K143625

truFreeze System by CSA Medical, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2015
Date Received
December 22, 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

Other clearances by CSA Medical, Inc.

  • K201183 — Vortex Radial Spray Catheter (December 7, 2020)
  • K171626 — truFreeze System (August 30, 2017)
  • K172041 — truFreeze System (July 27, 2017)
  • K171522 — truFreeze Rapid AV Spray Kit (July 14, 2017)
  • K163244 — truFreeze System (May 24, 2017)
  • K162695 — truFreeze System (October 25, 2016)
  • K161557 — truFreeze System (July 26, 2016)
  • K152668 — truFreeze System (October 14, 2015)
  • K150920 — truFreeze System (June 17, 2015)
  • K133258 — TRUFREEZE SYSTEM (June 19, 2014)

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