The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for Melodi Prime Breast Pump.
| Device ID | K143574 |
| 510k Number | K143574 |
| Device Name: | Melodi Prime Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Genadyne Biotechnologies, Inc. 16 Midland Ave Hicksville, NY 11801 |
| Contact | Chien Ming Goh |
| Correspondent | Chien Ming Goh Genadyne Biotechnologies, Inc. 16 Midland Ave Hicksville, NY 11801 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-17 |
| Decision Date | 2015-04-21 |
| Summary: | summary |