The following data is part of a premarket notification filed by Medivators Reprocessing Systems with the FDA for Medivators Advantage Plus Endoscope Reprocessor.
Device ID | K102996 |
510k Number | K102996 |
Device Name: | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR |
Classification | Accessories, Cleaning, For Endoscope |
Applicant | MEDIVATORS REPROCESSING SYSTEMS 14605 28TH AVE., NORTH Minneapolis, MN 55447 -4822 |
Contact | Lynn Lueders |
Correspondent | Lynn Lueders MEDIVATORS REPROCESSING SYSTEMS 14605 28TH AVE., NORTH Minneapolis, MN 55447 -4822 |
Product Code | FEB |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-07 |
Decision Date | 2011-01-13 |
Summary: | summary |