Device Classification Name |
staple, implantable
|
510(k) Number |
K111195 |
Device Name |
VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS |
Applicant |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Applicant Contact |
DENNIS HAHN |
Correspondent |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Correspondent Contact |
DENNIS HAHN |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 04/28/2011 |
Decision Date | 08/03/2011 |
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
|
|
|