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510(k) K031482

CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE by Cryomedical Instruemts , Ltd. — Product Code GXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2003
Date Received
May 12, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Surgical, Cryogenic
Device Class
Class II
Regulation Number
882.4250
Review Panel
NE
Submission Type

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