Device Classification Name |
staple, implantable
|
510(k) Number |
K121600 |
Device Name |
ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE |
Applicant |
ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD |
CINCINNATI,
OH
45242
|
|
Applicant Contact |
ASIFA VONHOF |
Correspondent |
ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD |
CINCINNATI,
OH
45242
|
|
Correspondent Contact |
ASIFA VONHOF |
Regulation Number | 878.4750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/01/2012 |
Decision Date | 07/16/2012 |
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
|
|
|