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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K844343
Device Name TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE
Applicant
Top Surgical Manufacturers Co.
7660 W. Fremont Ave.
Littleton,  CO  80123
Applicant Contact TOD IMAMURA
Correspondent
Top Surgical Manufacturers Co.
7660 W. Fremont Ave.
Littleton,  CO  80123
Correspondent Contact TOD IMAMURA
Regulation Number876.5540
Classification Product Code
FIE  
Date Received11/09/1984
Decision Date 01/08/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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