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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 K990716
Device Name GALLINI BYCUT NEEDLE
Applicant
Gallini U.S., LLC
3991 Glenside Dr., Suite F
Richmond,  VA  23229
Applicant Contact PAUL L HAWTHORNE
Correspondent
Gallini U.S., LLC
3991 Glenside Dr., Suite F
Richmond,  VA  23229
Correspondent Contact PAUL L HAWTHORNE
Regulation Number876.1075
Classification Product Code
KNW  
Date Received03/04/1999
Decision Date 05/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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