The following data is part of a premarket notification filed by Nova Health Systems, Inc. with the FDA for Nova Pillow.
| Device ID | K895477 |
| 510k Number | K895477 |
| Device Name: | NOVA PILLOW |
| Classification | Orthosis, Cervical |
| Applicant | NOVA HEALTH SYSTEMS, INC. 1001 LOWER LANDING RD. SUITE 409 Blackwood, NJ 08012 |
| Contact | Robert E Delano |
| Correspondent | Robert E Delano NOVA HEALTH SYSTEMS, INC. 1001 LOWER LANDING RD. SUITE 409 Blackwood, NJ 08012 |
| Product Code | IQK |
| CFR Regulation Number | 890.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-11 |
| Decision Date | 1990-01-10 |