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FDA 510(k) Application Details - K083157
Device Classification Name
System, Ablation, Microwave And Accessories
More FDA Info for this Device
510(K) Number
K083157
Device Name
System, Ablation, Microwave And Accessories
Applicant
H.S HOSPITAL SERVICE S.P.A.
6600 W. ROGERS CIRCLE
SUITES 1 & 2
BOCA RATON, FL 33487 US
Other 510(k) Applications for this Company
Contact
LUCIO IMPROTA
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
NEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/24/2008
Decision Date
09/29/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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