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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biopsy needle
510(k) Number K905556
Device Name HIGH SPEED CORE CUT BIOPSY GUN
Applicant
UNI-QUATRO INDUSTRIES CANADA, INC.
6471 KISTER RD.
NIAGARA FALLS, ONTARIO,  CA L2E 6X8
Applicant Contact SIEGFRIED GRUCHOT
Correspondent
UNI-QUATRO INDUSTRIES CANADA, INC.
6471 KISTER RD.
NIAGARA FALLS, ONTARIO,  CA L2E 6X8
Correspondent Contact SIEGFRIED GRUCHOT
Regulation Number876.1075
Classification Product Code
FCG  
Date Received12/11/1990
Decision Date 03/08/1991
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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