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510(k) K141485

ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE by Galil Medical , Ltd. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2014
Date Received
June 5, 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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