Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K061268 |
Device Name |
G-LIX TISSUE GRASPER |
Applicant |
USGI MEDICAL |
1140 CALLE CORDILLERA |
SAN CLEMENTE,
CA
92673
|
|
Applicant Contact |
MARY LOU MOONEY |
Correspondent |
USGI MEDICAL |
1140 CALLE CORDILLERA |
SAN CLEMENTE,
CA
92673
|
|
Correspondent Contact |
MARY LOU MOONEY |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 05/05/2006 |
Decision Date | 07/31/2006 |
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
|
|
|