The following data is part of a premarket notification filed by Moxxly, Inc. with the FDA for Moxxly Flow Collection System.
| Device ID | K170722 |
| 510k Number | K170722 |
| Device Name: | Moxxly Flow Collection System |
| Classification | Pump, Breast, Powered |
| Applicant | Moxxly, Inc. 1777 Yosemite Ave. Suite 235 San Francisco, CA 94124 |
| Contact | Cara Delzer |
| Correspondent | Rory A. Carrillo Moxxly, Inc. 1777 Yosemite Ave. Suite 235 San Francisco, CA 94124 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-09 |
| Decision Date | 2017-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856509007053 | K170722 | 000 |
| 00856509007046 | K170722 | 000 |
| 00856509007039 | K170722 | 000 |
| 00856509007015 | K170722 | 000 |