The following data is part of a premarket notification filed by Kean-rody Manufacturer with the FDA for Rody Breast Pump.
| Device ID | K840874 |
| 510k Number | K840874 |
| Device Name: | RODY BREAST PUMP |
| Classification | Pump, Breast, Non-powered |
| Applicant | KEAN-RODY MANUFACTURER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGY |
| CFR Regulation Number | 884.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-27 |
| Decision Date | 1984-07-23 |