The following data is part of a premarket notification filed by Medela Ag with the FDA for Symphony Breastpump, Symphony Reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery Version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental.
| Device ID | K151632 |
| 510k Number | K151632 |
| Device Name: | Symphony Breastpump, Symphony Reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery Version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental |
| Classification | Pump, Breast, Powered |
| Applicant | MEDELA AG LATTICHSTRASSE 4B Baar, CH 6341 |
| Contact | Orlando Antunes |
| Correspondent | Adrienne Lenz PATHWAY REGULATORY CONSULTING, LLC W324 S3649 COUNTY ROAD E Dousman, WI 53118 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-17 |
| Decision Date | 2015-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612367007566 | K151632 | 000 |