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510(k) K053535

VIVAWAVE MICROWAVE ABLATION SYSTEM by Valleylab — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2006
Date Received
December 19, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Ablation, Microwave And Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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