Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K971797 |
Device Name |
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT |
Applicant |
LOUISVILLE LABORATORIES, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
MARY MCNAMARA-CULLINANE |
Correspondent |
LOUISVILLE LABORATORIES, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
MARY MCNAMARA-CULLINANE |
Regulation Number | 884.1720
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/15/1997 |
Decision Date | 07/22/1997 |
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
|
|
|