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 Number | 876.1075
|
Classification Product Code |
|
Date Received | 09/17/2001 |
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
|
|
|