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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K911464
Device Name INTERSON DISPOSABLE BIOPSY NEEDLE
Applicant
Interson Corp.
7068 Koll Center Pkwy., #415
Pleasanton,  CA  94566
Applicant Contact MICHAEL CHRISTY
Correspondent
Interson Corp.
7068 Koll Center Pkwy., #415
Pleasanton,  CA  94566
Correspondent Contact MICHAEL CHRISTY
Regulation Number892.1560
Classification Product Code
IYO  
Date Received04/03/1991
Decision Date 09/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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