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510(k) K060144

SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS by Galil Medical , Ltd. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2006
Date Received
January 19, 2006
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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