The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Lifecare Nasal Mask Kit Cat. No. 06-800.
| Device ID | K894779 |
| 510k Number | K894779 |
| Device Name: | LIFECARE NASAL MASK KIT CAT. NO. 06-800 |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette, CO 80026 |
| Contact | Harold Ellerington |
| Correspondent | Harold Ellerington LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette, CO 80026 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-27 |
| Decision Date | 1990-01-12 |