The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for Lucina Model Melodi.
| Device ID | K102516 |
| 510k Number | K102516 |
| Device Name: | LUCINA MODEL MELODI |
| Classification | Pump, Breast, Powered |
| Applicant | GENADYNE BIOTECHNOLOGIES, INC. 65 WATERMILL LANE Great Neck, NY 11021 |
| Contact | Chien Ming(andrew)goh |
| Correspondent | Chien Ming(andrew)goh GENADYNE BIOTECHNOLOGIES, INC. 65 WATERMILL LANE Great Neck, NY 11021 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-02 |
| Decision Date | 2011-08-11 |
| Summary: | summary |