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510(k) K083493

MYOSCIENCE CRYO-TOUCH by Myoscience, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2009
Date Received
November 25, 2008
Clearance Type
Traditional
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 Myoscience, Inc.

  • K173763 — iovera system (February 28, 2018)
  • K161835 — iovera system (March 24, 2017)
  • K142866 — Myoscience iovera system (January 21, 2015)
  • K133453 — IOVERA (March 24, 2014)
  • K123516 — CRYO-TOUCH IV (January 10, 2013)
  • K120415 — CRYO-TOUCH III (June 22, 2012)
  • K102021 — CRYO-TOUCH II (September 17, 2010)
  • K100447 — MYOSCIENCE CRYO-TOUCH (June 25, 2010)

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