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510(k) K030281

CRYOTRON 2 CRYOTHERAPY DEVICE by Cryonic Medical North America — Product Code MLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2003
Date Received
January 27, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vapocoolant Device
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

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