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510(k) K070482

ISIS by Galil Medical , Ltd. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2007
Date Received
February 20, 2007
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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