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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 K962569
Device Name BIOMID BONE MARROW BIOPSY NEEDLE
Applicant
GALLINI INTL., INC.
1454 ROCKAWAY PKWY., SUITE 300
BROOKLYN,  NY  11236
Applicant Contact CATERINA E GALLUZZO
Correspondent
GALLINI INTL., INC.
1454 ROCKAWAY PKWY., SUITE 300
BROOKLYN,  NY  11236
Correspondent Contact CATERINA E GALLUZZO
Regulation Number876.1075
Classification Product Code
FCG  
Date Received07/01/1996
Decision Date 11/27/1996
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
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