Device Classification Name |
bag, urine collection, leg, for external use, sterile
|
510(k) Number |
K896129 |
Device Name |
URINARY LEG BAG |
Applicant |
CYPRESS MEDICAL PRODUCTS, LTD. |
1202 SOUTH ROUTE 31 |
MCHENRY,
IL
60050
|
|
Applicant Contact |
VARUN SONI |
Correspondent |
CYPRESS MEDICAL PRODUCTS, LTD. |
1202 SOUTH ROUTE 31 |
MCHENRY,
IL
60050
|
|
Correspondent Contact |
VARUN SONI |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 10/23/1989 |
Decision Date | 04/16/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|