The following data is part of a premarket notification filed by Smith & Davis Mfg. Co. with the FDA for Smith And Davis Pressure Therapy System.
| Device ID | K913654 |
| 510k Number | K913654 |
| Device Name: | SMITH AND DAVIS PRESSURE THERAPY SYSTEM |
| Classification | Bed, Air Fluidized |
| Applicant | SMITH & DAVIS MFG. CO. 1180 CENTRAL INDUSTRIAL AVE. St Louis, MO 63110 |
| Contact | Darrell Mcentire |
| Correspondent | Darrell Mcentire SMITH & DAVIS MFG. CO. 1180 CENTRAL INDUSTRIAL AVE. St Louis, MO 63110 |
| Product Code | INX |
| CFR Regulation Number | 890.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-16 |
| Decision Date | 1991-11-22 |