Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K944563 |
Device Name |
FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS |
Applicant |
MARLOW SURGICAL TECHNOLOGIES, INC. |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Applicant Contact |
ARTHUR S GODDARD |
Correspondent |
MARLOW SURGICAL TECHNOLOGIES, INC. |
1810 JOSEPH LLOYD PKWY. |
WILLOUGHBY,
OH
44094
|
|
Correspondent Contact |
ARTHUR S GODDARD |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 09/19/1994 |
Decision Date | 12/27/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|