Device Classification Name |
Stapler, Surgical
|
510(k) Number |
K851121 |
Device Name |
PI-PHEUMO INTESTINAL INSTRUMENT SET |
Applicant |
SURGEONS CHOICE, INC. |
BAKER & MCKENZIE |
815 CONNECTICUT AVENUE NW |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
DAVID B VANCE |
Correspondent |
SURGEONS CHOICE, INC. |
BAKER & MCKENZIE |
815 CONNECTICUT AVENUE NW |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
DAVID B VANCE |
Regulation Number | 878.4740
|
Classification Product Code |
|
Date Received | 03/19/1985 |
Decision Date | 04/25/1985 |
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
|
|
|