Device Classification Name |
Stapler, Surgical
|
510(k) Number |
K813170 |
Device Name |
ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER |
Applicant |
SURGEONS CHOICE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SURGEONS CHOICE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4740
|
Classification Product Code |
|
Date Received | 11/17/1981 |
Decision Date | 02/12/1982 |
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
|
|
|