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510(k) K130995

NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY by Nuance Medical, LLC — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2013
Date Received
April 10, 2013
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

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  • K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray (October 18, 2017)
  • K162218 — Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model (November 22, 2016)
  • K161337 — CryoDose H or Similar (July 12, 2016)

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