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510(k) K140584

ICEROD CX CRYOABLATION NEEDLE by Galil Medical , Ltd. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2014
Date Received
March 7, 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

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