Device Classification Name |
accessories, cleaning, for endoscope
|
510(k) Number |
K102996 |
FOIA Releasable 510(k) |
K102996
|
Device Name |
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR |
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 | 10/07/2010 |
Decision Date | 01/13/2011 |
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
|
|
|