510(k) K083157

HS AMICA by H.S Hospital Service S.P.A — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2009
Date Received
October 24, 2008
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