Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K905042 |
Device Name |
COMFORT SLEEVED ALL SILICONE FOLEY CATHETER |
Applicant |
ROCHESTER MEDICAL CORP. |
1500 NW 2ND AVE. |
P.O. BOX 188 |
STEWARTVILLE,
MN
55976
|
|
Applicant Contact |
RICHARD D FRYAR |
Correspondent |
ROCHESTER MEDICAL CORP. |
1500 NW 2ND AVE. |
P.O. BOX 188 |
STEWARTVILLE,
MN
55976
|
|
Correspondent Contact |
RICHARD D FRYAR |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 11/07/1990 |
Decision Date | 01/18/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|