The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Side Rail Pads.
| Device ID | K823821 |
| 510k Number | K823821 |
| Device Name: | SIDE RAIL PADS |
| Classification | Bed, Manual |
| Applicant | DANEK MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FNJ |
| CFR Regulation Number | 880.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-17 |
| Decision Date | 1983-01-21 |