The following data is part of a premarket notification filed by Sleep Devices, Inc. with the FDA for Sona Pillow.
Device ID | K040161 |
510k Number | K040161 |
Device Name: | SONA PILLOW |
Classification | Pillow, Cervical (for Mild Sleep Apnea) |
Applicant | SLEEP DEVICES, INC. 720 WEST OAK STREET SUITE 210 Kissimmee, FL 34741 |
Contact | Najeeb A Zuberi |
Correspondent | Najeeb A Zuberi SLEEP DEVICES, INC. 720 WEST OAK STREET SUITE 210 Kissimmee, FL 34741 |
Product Code | MYB |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-01-23 |
Decision Date | 2004-04-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SONA PILLOW 76658940 3207263 Live/Registered |
LIFESTYLE PRODUCTS LLC 2006-04-24 |
SONA PILLOW 76569485 not registered Dead/Abandoned |
Sleep Devices, Inc. 2004-01-12 |