The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Cushion-flex Tm-cpap Face Mask.
| Device ID | K854458 |
| 510k Number | K854458 |
| Device Name: | CUSHION-FLEX TM-CPAP FACE MASK |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | LIFE DESIGN SYSTEMS, INC. 11017 WEST LAYTON AVE. Milwaukee, WI 53228 |
| Contact | Gilbert M Kirk |
| Correspondent | Gilbert M Kirk LIFE DESIGN SYSTEMS, INC. 11017 WEST LAYTON AVE. Milwaukee, WI 53228 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-06 |
| Decision Date | 1986-01-15 |