Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K090792 |
Device Name |
MITAKA UNIARM |
Applicant |
MITAKA KOHKI CO., LTD. |
2337 LUCKY JOHN DRIVE |
PARK CITY,
UT
84060
|
|
Applicant Contact |
MAXWELL STURGIS |
Correspondent |
MITAKA KOHKI CO., LTD. |
2337 LUCKY JOHN DRIVE |
PARK CITY,
UT
84060
|
|
Correspondent Contact |
MAXWELL STURGIS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/24/2009 |
Decision Date | 07/06/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|