Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K950632 |
Device Name |
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP |
Applicant |
INNERDYNE, INC. |
5060 WEST AMELIA EARHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
RICK GAYKOWSKI |
Correspondent |
INNERDYNE, INC. |
5060 WEST AMELIA EARHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
RICK GAYKOWSKI |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/13/1995 |
Decision Date | 05/12/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|