Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K960810 |
Device Name |
BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM |
Applicant |
MARLO SURGICAL TECHNOLOGY |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Applicant Contact |
ARTHUR S GODDARD |
Correspondent |
MARLO SURGICAL TECHNOLOGY |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Correspondent Contact |
ARTHUR S GODDARD |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 02/28/1996 |
Decision Date | 10/21/1996 |
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
|
|
|