The following data is part of a premarket notification filed by Sleep Science Partners, Inc. with the FDA for Puresleep (otc Use).
| Device ID | K190058 |
| 510k Number | K190058 |
| Device Name: | PureSleep (OTC Use) |
| Classification | Device, Anti-snoring |
| Applicant | Sleep Science Partners, Inc. 900 Larkspur Landing Circle Suite 207 Larkspur, CA 94939 |
| Contact | Noel P. Lindsay |
| Correspondent | Valerie Followell Lean RAQA, LLC 12602 North Summerwind Drive Marana, AZ 85658 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-11 |
| Decision Date | 2019-04-11 |