Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K924611 |
Device Name |
IRRIGATION PUMP AND TUBING SET |
Applicant |
MARLO SURGICAL TECHNOLOGY |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Applicant Contact |
CRAIG R LANESE |
Correspondent |
MARLO SURGICAL TECHNOLOGY |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Correspondent Contact |
CRAIG R LANESE |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 09/11/1992 |
Decision Date | 06/30/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|