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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 K962905
Device Name TX BIOPSY NEEDLE
Applicant
Gallini S.R.L.
1454 Rockaway Pkwy.
Suite #300
Brooklyn,  NY  11236
Applicant Contact CATERINA E GALLUZZO
Correspondent
Gallini S.R.L.
1454 Rockaway Pkwy.
Suite #300
Brooklyn,  NY  11236
Correspondent Contact CATERINA E GALLUZZO
Regulation Number876.1075
Classification Product Code
FCG  
Date Received07/25/1996
Decision Date 10/11/1996
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
Predetermined Change
Control Plan Authorized		 No
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