The following data is part of a premarket notification filed by Medela Ag with the FDA for Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty.
| Device ID | K150499 |
| 510k Number | K150499 |
| Device Name: | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty |
| Classification | Pump, Breast, Powered |
| Applicant | MEDELA AG LATTICHSTRASSE 4B Baar, CH 6341 |
| Contact | Orlando Antunes |
| Correspondent | Adrienne Lenz PATHWAY REGULATORY CONSULTING, LLC W324S3649 COUNTY ROAD E Dousman, WI 53118 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-26 |
| Decision Date | 2015-04-21 |
| Summary: | summary |