The following data is part of a premarket notification filed by Lifesleep Systems, Inc. with the FDA for Pillowpositive Cervical Pillow.
| Device ID | K990871 |
| 510k Number | K990871 |
| Device Name: | PILLOWPOSITIVE CERVICAL PILLOW |
| Classification | Pillow, Cervical (for Mild Sleep Apnea) |
| Applicant | LIFESLEEP SYSTEMS, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein LIFESLEEP SYSTEMS, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | MYB |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-16 |
| Decision Date | 1999-06-10 |
| Summary: | summary |