The following data is part of a premarket notification filed by Jefferson Industries, Inc. with the FDA for Gel Flotation Cushion.
| Device ID | K813225 |
| 510k Number | K813225 |
| Device Name: | GEL FLOTATION CUSHION |
| Classification | Cushion, Flotation |
| Applicant | JEFFERSON INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIC |
| CFR Regulation Number | 890.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-10 |
| Decision Date | 1981-12-03 |