Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K971801 |
Device Name |
LAPAROTOMY 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 | 876.5130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/15/1997 |
Decision Date | 07/22/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|