The following data is part of a premarket notification filed by Medela Llc with the FDA for Pump In Style.
| Device ID | K200508 |
| 510k Number | K200508 |
| Device Name: | Pump In Style |
| 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 | 2020-03-02 |
| Decision Date | 2020-06-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10020451412655 | K200508 | 000 |
| 10020451401468 | K200508 | 000 |
| 10020451401451 | K200508 | 000 |
| 10020451401444 | K200508 | 000 |
| 10020451401437 | K200508 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PUMP IN STYLE 75345375 2198035 Live/Registered |
Medela Holding AG 1997-08-22 |