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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K131925
Device Name HS NOTA
Applicant
H.S. HOSPITAL SERVICES S.P.A.
10147 UMBERLAND PLACE
BOCA RATON,  FL  33428
Applicant Contact LUCIO IMPROTA
Correspondent
H.S. HOSPITAL SERVICES S.P.A.
10147 UMBERLAND PLACE
BOCA RATON,  FL  33428
Correspondent Contact LUCIO IMPROTA
Regulation Number876.1075
Classification Product Code
FCG  
Date Received06/26/2013
Decision Date 10/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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