FDA 510(k) Application Details - K083157

Device Classification Name System, Ablation, Microwave And Accessories

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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
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Contact LUCIO IMPROTA
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Regulation Number 878.4400

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Classification Product Code NEY
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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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