Device Classification Name |
Catheter, Straight
|
510(k) Number |
K993226 |
Device Name |
MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006 |
Applicant |
MEMCATH TECHNOLOGIES LLC. |
1777 OAKDALE AVE. |
WEST ST. PAUL,
MN
55118 -4031
|
|
Applicant Contact |
MARC JAKER |
Correspondent |
MEMCATH TECHNOLOGIES LLC. |
1777 OAKDALE AVE. |
WEST ST. PAUL,
MN
55118 -4031
|
|
Correspondent Contact |
MARC JAKER |
Regulation Number | 876.5130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/27/1999 |
Decision Date | 12/10/1999 |
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
|
|
|