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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K182605
Device Name HS AMICA devices family
Applicant
H.S Hospital Service S.P.A
Via A. Vacchi, 23/25
Aprilia (Lt),  IT 04011
Applicant Contact Laura Lenzi
Correspondent
Isemed S.R.L.
Via P. Togliatti, 19/X
Imola,  IT 40026
Correspondent Contact Silvia Scarpellini
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/21/2018
Decision Date 10/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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