The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Air-flo Alternating Pressure Pad System.
| Device ID | K780906 |
| 510k Number | K780906 |
| Device Name: | AIR-FLO ALTERNATING PRESSURE PAD SYSTEM |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | GAYMAR INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-02 |
| Decision Date | 1978-08-10 |