Device Classification Name |
Staple, Implantable
|
510(k) Number |
K101378 |
Device Name |
FRANKENMAN SURGICAL STAPLERS |
Applicant |
SUZHOU FRANKENMAN MEDICAL EQUIPMENT CO., LTD. |
1705 S. CAPITAL OF TEXAS HWY |
SUITE 500 |
AUSTIN,
TX
78746
|
|
Applicant Contact |
JEAN ASQUITH |
Correspondent |
SUZHOU FRANKENMAN MEDICAL EQUIPMENT CO., LTD. |
1705 S. CAPITAL OF TEXAS HWY |
SUITE 500 |
AUSTIN,
TX
78746
|
|
Correspondent Contact |
JEAN ASQUITH |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 05/17/2010 |
Decision Date | 06/29/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|