Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K970716 |
Device Name |
OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE |
Applicant |
OPTICON MEDICAL, INC. |
14505 21ST AVENUE NORTH |
SUITE #216 |
MINNEAPOLIS,
MN
55447
|
|
Applicant Contact |
GREG SACHS |
Correspondent |
OPTICON MEDICAL, INC. |
14505 21ST AVENUE NORTH |
SUITE #216 |
MINNEAPOLIS,
MN
55447
|
|
Correspondent Contact |
GREG SACHS |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 02/27/1997 |
Decision Date | 05/16/1997 |
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
|
|
|