The following data is part of a premarket notification filed by Medivators Reprocessing Systems with the FDA for Modular Disinfection System (mds) For Endoscope Reprocessing.
| Device ID | K063876 |
| 510k Number | K063876 |
| Device Name: | MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING |
| 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 | 2006-12-29 |
| Decision Date | 2007-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333241958 | K063876 | 000 |
| 04961333241941 | K063876 | 000 |
| 04961333241934 | K063876 | 000 |
| 04961333241927 | K063876 | 000 |
| 04961333241910 | K063876 | 000 |