Device Classification Name |
Staple, Implantable
|
510(k) Number |
K083519 |
Device Name |
AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS |
Applicant |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
60 MIDDLETOWN AVENUE |
NORTH HAVEN,
CT
06473
|
|
Applicant Contact |
FRANK GIANELLI |
Correspondent |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
60 MIDDLETOWN AVENUE |
NORTH HAVEN,
CT
06473
|
|
Correspondent Contact |
FRANK GIANELLI |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 11/26/2008 |
Decision Date | 04/10/2009 |
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
|
|
|