The following data is part of a premarket notification filed by Luv N' Care, Ltd. with the FDA for Nuby Natural Touch Rhythm Dual Action Electric Breast Pump.
| Device ID | K100385 |
| 510k Number | K100385 |
| Device Name: | NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | LUV N' CARE, LTD. 1705. S CAPITOL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Jean Asquith |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-03-24 |
| Summary: | summary |