Device Classification Name |
staple, implantable
|
510(k) Number |
K131705 |
Device Name |
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY |
Applicant |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
60 Middletown Ave |
North Haven,
CT
06473
|
|
Applicant Contact |
KATHERINE ROBERTSON |
Correspondent |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
60 Middletown Ave |
North Haven,
CT
06473
|
|
Correspondent Contact |
KATHERINE ROBERTSON |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 06/11/2013 |
Decision Date | 07/01/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|