Device Classification Name |
catheter, urological (antimicrobial) and accessories
|
510(k) Number |
K971627 |
Device Name |
SILICONE ANTIBACTERIAL FOLEY CATHETER |
Applicant |
ROCHESTER MEDICAL CORP. |
ONE ROCHESTER MEDICAL DR. |
STEWARTVILLE,
MN
55976
|
|
Applicant Contact |
RICHARD D FRYAR |
Correspondent |
ROCHESTER MEDICAL CORP. |
ONE ROCHESTER MEDICAL DR. |
STEWARTVILLE,
MN
55976
|
|
Correspondent Contact |
RICHARD D FRYAR |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 05/02/1997 |
Decision Date | 01/13/1998 |
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
|
|
|