The following data is part of a premarket notification filed by Unique Flotation Systems, Inc. with the FDA for Stage Iv, Air-fluidize Bed.
| Device ID | K904008 |
| 510k Number | K904008 |
| Device Name: | STAGE IV, AIR-FLUIDIZE BED |
| Classification | Bed, Air Fluidized |
| Applicant | UNIQUE FLOTATION SYSTEMS, INC. 121 ENTERPRISE COURT Corona, CA 91720 |
| Contact | Robert J Nangle |
| Correspondent | Robert J Nangle UNIQUE FLOTATION SYSTEMS, INC. 121 ENTERPRISE COURT Corona, CA 91720 |
| Product Code | INX |
| CFR Regulation Number | 890.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-29 |
| Decision Date | 1990-10-10 |