The following data is part of a premarket notification filed by Neonatal Loving Kare, Inc. with the FDA for Nurture Rest.
| Device ID | K172962 |
| 510k Number | K172962 |
| Device Name: | Nurture Rest |
| Classification | Infant Positioner, Rx, Use In Highly Monitored Setting |
| Applicant | Neonatal Loving Kare, Inc. 1702 Treasure Lake Dubois, PA 15801 |
| Contact | Nicole Sawyers |
| Correspondent | Nicole Spaniel Regulatory And Quality Solutions, Inc. 2790 Mosside Blvd #800 Monroeville, PA 15146 |
| Product Code | OUW |
| CFR Regulation Number | 880.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2018-01-18 |
| Summary: | summary |