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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 K002947
Device Name BIOMOL ASPIRATION BIOPSY NEEDLE
Applicant
H.S. HOSPITAL SERVICE S.R.L.
131 HIGHWAY DR.
SOUTH GLASTONBURY,  CT  06073
Applicant Contact LUCIO IMPROTA
Correspondent
H.S. HOSPITAL SERVICE S.R.L.
131 HIGHWAY DR.
SOUTH GLASTONBURY,  CT  06073
Correspondent Contact LUCIO IMPROTA
Regulation Number876.1075
Classification Product Code
FCG  
Date Received09/21/2000
Decision Date 12/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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