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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K130616
Device Name MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES
Applicant
BIOPSYBELL S.R.L.
62 GERDES AVE.
VERONA,  NJ  07004
Applicant Contact WILLER GHELFI
Correspondent
BIOPSYBELL S.R.L.
62 GERDES AVE.
VERONA,  NJ  07004
Correspondent Contact WILLER GHELFI
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
FCG  
Date Received03/07/2013
Decision Date 02/07/2014
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
Recalls CDRH Recalls
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