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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 K860449
Device Name MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE
Applicant
TOP CORP.
7660 WEST FREEMONT AVE.
LITTLETON,  CO  80123
Applicant Contact TADAYOSHI IMAMURA
Correspondent
TOP CORP.
7660 WEST FREEMONT AVE.
LITTLETON,  CO  80123
Correspondent Contact TADAYOSHI IMAMURA
Regulation Number876.5540
Classification Product Code
FIE  
Date Received02/04/1986
Decision Date 02/26/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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