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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 K970872
Device Name PAN (CHIBA ASPIRATING NEEDLE)
Applicant
Gallini Intl., Inc.
4405 Cox Rd., Suite 110
Glen Allen,  VA  23060
Applicant Contact PAUL L HAWTHORNE
Correspondent
Gallini Intl., Inc.
4405 Cox Rd., Suite 110
Glen Allen,  VA  23060
Correspondent Contact PAUL L HAWTHORNE
Regulation Number876.1075
Classification Product Code
KNW  
Date Received03/10/1997
Decision Date 05/21/1997
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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