The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Medela Battery Operated Breast Pump.
| Device ID | K901344 |
| 510k Number | K901344 |
| Device Name: | MEDELA BATTERY OPERATED BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | MEDELA, INC. C/O BURDITT & RADZIUS 333 WEST WACKER DR., STE. 2600 Chicago, IL 60606 |
| Contact | John F Lemker |
| Correspondent | John F Lemker MEDELA, INC. C/O BURDITT & RADZIUS 333 WEST WACKER DR., STE. 2600 Chicago, IL 60606 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-22 |
| Decision Date | 1990-08-06 |