The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Medela Symphony Breast Pump, Model 024.
| Device ID | K020518 |
| 510k Number | K020518 |
| Device Name: | MEDELA SYMPHONY BREAST PUMP, MODEL 024 |
| Classification | Pump, Breast, Powered |
| Applicant | MEDELA, INC. LAETTICHSTRASSE 4B Baar, Zug,, CH 6341 |
| Contact | Werner Frei |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-02-19 |
| Decision Date | 2002-03-07 |
| Summary: | summary |