The following data is part of a premarket notification filed by Medivators Inc. with the FDA for Advantage Plus Pass-thru.
| Device ID | K172677 |
| 510k Number | K172677 |
| Device Name: | Advantage Plus Pass-Thru |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | Medivators Inc. 14605 28th Avenue North Minneapolis, MN 55447 |
| Contact | Megan Skaar |
| Correspondent | Megan Skaar Medivators Inc. 14605 28th Avenue North Minneapolis, MN 55447 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-05 |
| Decision Date | 2017-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00677964095832 | K172677 | 000 |