Device Classification Name |
system, urine drainage, closed, for nonindwelling catheter, sterile
|
510(k) Number |
K882714 |
Device Name |
URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450 |
Applicant |
LSL INDUSTRIES, INC. |
7383 NORTH ROGERS AVE. |
CHICAGO,
IL
60626
|
|
Applicant Contact |
ASH LUTHRA |
Correspondent |
LSL INDUSTRIES, INC. |
7383 NORTH ROGERS AVE. |
CHICAGO,
IL
60626
|
|
Correspondent Contact |
ASH LUTHRA |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 07/01/1988 |
Decision Date | 01/31/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|