Device Classification Name |
staple, implantable
|
510(k) Number |
K120258 |
Device Name |
DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS |
Applicant |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
60 Middletown Ave |
North Haven,
CT
06473
|
|
Applicant Contact |
JENNIFER BRENNAN |
Correspondent |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
60 Middletown Ave |
North Haven,
CT
06473
|
|
Correspondent Contact |
JENNIFER BRENNAN |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 01/27/2012 |
Decision Date | 02/29/2012 |
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
|
|
|