The following data is part of a premarket notification filed by Medela Llc with the FDA for Pump In Style Advanced, Advanced Personal Double Breastpump.
| Device ID | K181937 |
| 510k Number | K181937 |
| Device Name: | Pump In Style Advanced, Advanced Personal Double Breastpump |
| Classification | Pump, Breast, Powered |
| Applicant | Medela LLC 1101 Corporate Drive Mchenry, IL 60050 |
| Contact | Pj Pasia |
| Correspondent | Pj Pasia Medela LLC 1101 Corporate Drive Mchenry, IL 60050 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-19 |
| Decision Date | 2018-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10020451364480 | K181937 | 000 |
| 10020451364527 | K181937 | 000 |
| 10020451364510 | K181937 | 000 |
| 10020451364503 | K181937 | 000 |
| 10020451364466 | K181937 | 000 |