Device Classification Name |
device, incontinence, urosheath type, sterile
|
510(k) Number |
K923136 |
Device Name |
MALE EXTERNAL 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 | 876.5250
|
Classification Product Code |
|
Date Received | 06/29/1992 |
Decision Date | 12/03/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|