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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 K895725
Device Name BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES
Applicant
Interson Corp.
7068 Koll Center Pkwy., #415
Pleasanton,  CA  94566
Applicant Contact MARK F HAYWARD
Correspondent
Interson Corp.
7068 Koll Center Pkwy., #415
Pleasanton,  CA  94566
Correspondent Contact MARK F HAYWARD
Regulation Number876.1075
Classification Product Code
FCG  
Date Received09/25/1989
Decision Date 11/06/1989
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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