Device Classification Name |
system, urine drainage, closed, for nonindwelling catheter, sterile
|
510(k) Number |
K964219 |
Device Name |
ZIP CONDOM CATHETER |
Applicant |
GOULTER MEDICAL, INC. |
1000 BURNETT AVE. |
SUITE 450 |
CONCORD,
CA
94520
|
|
Applicant Contact |
DAVID W SCHLERF |
Correspondent |
GOULTER MEDICAL, INC. |
1000 BURNETT AVE. |
SUITE 450 |
CONCORD,
CA
94520
|
|
Correspondent Contact |
DAVID W SCHLERF |
Regulation Number | 876.5250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/22/1996 |
Decision Date | 08/11/1997 |
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
|
|
|