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510(k) K234002

ICEfx Cryoablation System (FPRCH8000-02) by Boston Scientific — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2024
Date Received
December 19, 2023
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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