| Device Classification Name |
accessories, cleaning, for endoscope
|
|---|
| 510(K) Number |
K082988 |
|---|
| Device Name |
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT |
|---|
| Applicant |
| MEDIVATORS REPROCESSING SYSTEMS |
| 14605 28th ave., north |
|
minneapolis,
MN
55447 4822
|
|
| Contact |
lynn lueders |
| Regulation Number | 876.1500
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 10/08/2008 |
|---|
| Decision Date | 02/13/2009 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Gastroenterology/Urology
|
|---|
| Review Advisory Committee |
General Hospital
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
