The following data is part of a premarket notification filed by A Cute Baby, Inc. with the FDA for Rumble Tuff Electric Breast Pump.
| Device ID | K200712 |
| 510k Number | K200712 |
| Device Name: | Rumble Tuff Electric Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | A Cute Baby, Inc. 865 N 1430 W Orem, UT 84057 |
| Contact | Matthew Kho |
| Correspondent | Matthew Kho A Cute Baby, Inc. 865 N 1430 W Orem, UT 84057 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-18 |
| Decision Date | 2020-04-17 |