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510(k) K072651

CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM by CSA Medical, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2007
Date Received
September 19, 2007
Clearance Type
Abbreviated
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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  • K143625 — truFreeze System (January 15, 2015)

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