Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K965045 |
Device Name |
TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE |
Applicant |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Applicant Contact |
IVAN S PLACKO |
Correspondent |
ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Correspondent Contact |
IVAN S PLACKO |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 12/17/1996 |
Decision Date | 05/05/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|