Device Classification Name |
staple, implantable
|
510(k) Number |
K133499 |
FOIA Releasable 510(k) |
K133499
|
Device Name |
SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA |
Applicant |
SUZHOU BEINUO MEDICAL EQUIPMENT CO. LTD. |
816 CONGRESS AVE., STE 1400 |
AUSTIN,
TX
78701
|
|
Applicant Contact |
ROBERT SEIPLE, RAC |
Correspondent |
SUZHOU BEINUO MEDICAL EQUIPMENT CO. LTD. |
816 CONGRESS AVE., STE 1400 |
AUSTIN,
TX
78701
|
|
Correspondent Contact |
ROBERT SEIPLE, RAC |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 11/14/2013 |
Decision Date | 01/14/2014 |
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
|
|
|