Device Classification Name |
catheter, urological
|
510(k) Number |
K896053 |
Device Name |
ALL SILICONE FOLEY CATHETER |
Applicant |
ROCHESTER MEDICAL CORP. |
210 WOODLAKE DRIVE SE |
ROCHESTER,
MN
55904
|
|
Applicant Contact |
R. D FRYAR |
Correspondent |
ROCHESTER MEDICAL CORP. |
210 WOODLAKE DRIVE SE |
ROCHESTER,
MN
55904
|
|
Correspondent Contact |
R. D FRYAR |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 10/18/1989 |
Decision Date | 02/12/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|