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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 K963894
Device Name SMARTGUIDE
Applicant
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973
Applicant Contact FRANK FERGUSON
Correspondent
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973
Correspondent Contact FRANK FERGUSON
Regulation Number876.1075
Classification Product Code
FCG  
Date Received09/27/1996
Decision Date 03/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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