The following data is part of a premarket notification filed by Medela, Inc with the FDA for Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double Pumping Tubing Kit, Retail, Connector Spare Parts Kit, Silicone Membrane, Retail, Power Adaptor, Retail.
| Device ID | K161725 |
| 510k Number | K161725 |
| Device Name: | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double Pumping Tubing Kit, Retail, Connector Spare Parts Kit, Silicone Membrane, Retail, Power Adaptor, Retail |
| Classification | Pump, Breast, Powered |
| Applicant | MEDELA, INC 1101 CORPORATE DRIVE Mchenry, IL 60050 |
| Contact | Robert Sokolowski |
| Correspondent | Adrienne Lenz PATHWAY REGULATORY CONSULTING, LLC W324S3649 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 | 2016-06-22 |
| Decision Date | 2016-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10020451367504 | K161725 | 000 |
| 20020451582003 | K161725 | 000 |