Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K041983 |
Device Name |
OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 |
Applicant |
OPTICON MEDICAL |
7001 POST RD., SUITE 100 |
DUBLIN,
OH
43016
|
|
Applicant Contact |
GLENN D BRUNNER |
Correspondent |
OPTICON MEDICAL |
7001 POST RD., SUITE 100 |
DUBLIN,
OH
43016
|
|
Correspondent Contact |
GLENN D BRUNNER |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 07/23/2004 |
Decision Date | 11/17/2004 |
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
|
Recalls |
CDRH Recalls
|
|
|