Device Classification Name |
Stapler, Surgical
|
510(k) Number |
K892927 |
Device Name |
PROXIMATE LINEAR CUTTER THICK TISSUE INST. |
Applicant |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Applicant Contact |
JAMES O'DONNELL |
Correspondent |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Correspondent Contact |
JAMES O'DONNELL |
Regulation Number | 878.4740
|
Classification Product Code |
|
Date Received | 04/21/1989 |
Decision Date | 05/26/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|