The following data is part of a premarket notification filed by Medivators, Inc. with the FDA for Defendo Bronchoscopy Suction Valve.
| Device ID | K151522 |
| 510k Number | K151522 |
| Device Name: | DEFENDO Bronchoscopy Suction Valve |
| Classification | Bronchoscope Accessory |
| Applicant | MEDIVATORS, INC. 3150 POLLOK DR. Conroe, TX 77303 |
| Contact | Jeff Kasoff |
| Correspondent | Kinnari Shah MEDIVATORS INC. 14605 28th Ave N Minneapolis, MN 55447 |
| Product Code | KTI |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-05 |
| Decision Date | 2015-09-17 |
| Summary: | summary |