Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K954774 |
Device Name |
SHIELDED TROCAR (OBTURATOR) |
Applicant |
GABRIS SURGICAL CORP. |
1432 NORTH GREAT NECK RD., |
SUITE 204 |
VIRGINIA BEACH,
VA
23454
|
|
Applicant Contact |
BARBARA E KENNY |
Correspondent |
GABRIS SURGICAL CORP. |
1432 NORTH GREAT NECK RD., |
SUITE 204 |
VIRGINIA BEACH,
VA
23454
|
|
Correspondent Contact |
BARBARA E KENNY |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 10/17/1995 |
Decision Date | 06/07/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|