The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Freeway Nebulizer Compressor.
| Device ID | K895592 |
| 510k Number | K895592 |
| Device Name: | FREEWAY NEBULIZER COMPRESSOR |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette, CO 80026 |
| Contact | R Ellerington |
| Correspondent | R Ellerington LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette, CO 80026 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-15 |
| Decision Date | 1989-11-21 |