Freestyle Flex
Pump, Breast, Powered
Medela AG
The following data is part of a premarket notification filed by Medela Ag with the FDA for Freestyle Flex.
Pre-market Notification Details
| Device ID | K191653 |
| 510k Number | K191653 |
| Device Name: | Freestyle Flex |
| Classification | Pump, Breast, Powered |
| Applicant | Medela AG Laettichstrasse 4b Baar Zug, CH Ch-6341 |
| Contact | Judith Bernardo |
| Correspondent | Adrienne Lenz Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, DC 20005 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-20 |
| Decision Date | 2019-10-17 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612367071918 | K191653 | 000 |
| 07612367071727 | K191653 | 000 |
| 07612367071734 | K191653 | 000 |
Trademark Results [Freestyle Flex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FREESTYLE FLEX 79268008 not registered Live/Pending |
Medela Holding AG 2019-06-27 |
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