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510(k) K061865

FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 by Guidant Corp. — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2006
Date Received
July 3, 2006
Clearance Type
Special
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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