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
|
|
Applicant Contact |
LYNN LUEDERS |
Correspondent |
MEDIVATORS REPROCESSING SYSTEMS |
14605 28TH AVE., NORTH |
MINNEAPOLIS,
MN
55447 -4822
|
|
Correspondent Contact |
LYNN LUEDERS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/07/2008 |
Decision Date | 02/13/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|