The following data is part of a premarket notification filed by Medivators Reprocessing Systems with the FDA for Medivators Advantage Plus Endoscope Reprocessing System, Rapicide Pa High Level Disinfectant.
| Device ID | K082988 |
| 510k Number | K082988 |
| Device Name: | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT |
| 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 | 2008-10-07 |
| Decision Date | 2009-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00677964044755 | K082988 | 000 |
| 30677964090173 | K082988 | 000 |
| 30677964063610 | K082988 | 000 |
| 40677964023628 | K082988 | 000 |
| 40677964023604 | K082988 | 000 |