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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 K013109
Device Name SONOPSY
Applicant
Hakko Medical Co., Ltd.
7-9 Kamimeguro 1-Chome
Meguro-Ku, Tokyo,  JP 153
Applicant Contact SHIRO JITAGAWA
Correspondent
Hakko Medical Co., Ltd.
7-9 Kamimeguro 1-Chome
Meguro-Ku, Tokyo,  JP 153
Correspondent Contact SHIRO JITAGAWA
Regulation Number876.1075
Classification Product Code
FCG  
Date Received09/17/2001
Decision Date 03/12/2002
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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