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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 K973152
Device Name GALLINI ABS DEVICE
Applicant
GALLINI U.S., LLC.
4211 HARWIN PLACE, SUIET 315
GLEN ALLEN,  VA  23060
Applicant Contact PAUL L HAWTHORNE
Correspondent
GALLINI U.S., LLC.
4211 HARWIN PLACE, SUIET 315
GLEN ALLEN,  VA  23060
Correspondent Contact PAUL L HAWTHORNE
Regulation Number876.1075
Classification Product Code
KNW  
Date Received08/22/1997
Decision Date 01/09/1998
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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