The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Modified Cushion-flex(tm).
| Device ID | K890108 |
| 510k Number | K890108 |
| Device Name: | MODIFIED CUSHION-FLEX(TM) |
| Classification | Mask, Gas, Anesthetic |
| Applicant | LIFE DESIGN SYSTEMS, INC. 5900 WEST FRANKLIN DR. Franklin, WI 53132 |
| Contact | Alan E Whitmarsh |
| Correspondent | Alan E Whitmarsh LIFE DESIGN SYSTEMS, INC. 5900 WEST FRANKLIN DR. Franklin, WI 53132 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-03 |
| Decision Date | 1989-01-24 |