The following data is part of a premarket notification filed by Medivators with the FDA for Endo Smart Bottle, Rinse And Insufflation System.
| Device ID | K140753 |
| 510k Number | K140753 |
| Device Name: | ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | MEDIVATORS 14605 28TH AVE. N. Minneapolis, MN 55447 |
| Contact | Kinnari Shah |
| Correspondent | Kinnari Shah MEDIVATORS 14605 28TH AVE. N. Minneapolis, MN 55447 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-26 |
| Decision Date | 2014-07-15 |
| Summary: | summary |