Device Classification Name |
coagulator-cutter, endoscopic, bipolar (and accessories)
|
510(k) Number |
K911699 |
Device Name |
STI TISSUE MANIPULATOR |
Applicant |
SURGICAL TECHNOLOGIES, INC. |
750 GODDARD AVE. |
CHESTERFIELD,
MO
63005
|
|
Applicant Contact |
ALAN T BECKMAN |
Correspondent |
SURGICAL TECHNOLOGIES, INC. |
750 GODDARD AVE. |
CHESTERFIELD,
MO
63005
|
|
Correspondent Contact |
ALAN T BECKMAN |
Regulation Number | 884.4150
|
Classification Product Code |
|
Date Received | 04/16/1991 |
Decision Date | 06/13/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|