The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Pressure Relief Seat Cushion.
| Device ID | K842380 |
| 510k Number | K842380 |
| Device Name: | PRESSURE RELIEF SEAT CUSHION |
| Classification | Cushion, Flotation |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KIC |
| CFR Regulation Number | 890.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-18 |
| Decision Date | 1984-06-28 |