FDA 510(k) Application Details - K150112

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K150112
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant HS HOSPITAL SERVICE SPA
Via A. Vacchi, 23/25
Aprilia 04011 IT
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Contact Laura Lenzi
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 01/20/2015
Decision Date 09/10/2015
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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