Device Classification Name |
system, urine drainage, closed, for nonindwelling catheter, sterile
|
510(k) Number |
K890465 |
Device Name |
CLOSED SYSTEM URINARY DRAINAGE 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 | 01/31/1989 |
Decision Date | 05/23/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|