The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Cushion-flex Tm.
| Device ID | K843169 |
| 510k Number | K843169 |
| Device Name: | CUSHION-FLEX TM |
| Classification | Mask, Gas, Anesthetic |
| Applicant | LIFE DESIGN SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-13 |
| Decision Date | 1984-08-20 |