The following data is part of a premarket notification filed by Med-life, Inc. with the FDA for Head-up Supine Safety Support Cushion.
| Device ID | K821306 |
| 510k Number | K821306 |
| Device Name: | HEAD-UP SUPINE SAFETY SUPPORT CUSHION |
| Classification | Support, Head, Surgical, Ent |
| Applicant | MED-LIFE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EPW |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-04 |
| Decision Date | 1982-06-07 |