Device Classification Name |
staple, implantable
|
510(k) Number |
K102632 |
Device Name |
ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER |
Applicant |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Applicant Contact |
RENEE ROWE |
Correspondent |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Correspondent Contact |
RENEE ROWE |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 09/13/2010 |
Decision Date | 10/07/2010 |
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
|
|
|