The following data is part of a premarket notification filed by Modela Ag with the FDA for Basic, Dominant Flex.
| Device ID | K170329 |
| 510k Number | K170329 |
| Device Name: | Basic, Dominant Flex |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | Modela AG Lattichstrasse 4b Baar, CH 6341 |
| Contact | Markus Butler |
| Correspondent | Adrienne Lenz Pathway Regulatory Consulting, LLC W324S3649 County Road E Dousman, WI 53118 |
| Product Code | BTA |
| Subsequent Product Code | HDB |
| Subsequent Product Code | MUU |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-02 |
| Decision Date | 2017-03-24 |
| Summary: | summary |