The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Lifecare Exhalation Valve #06-699.
Device ID | K873570 |
510k Number | K873570 |
Device Name: | LIFECARE EXHALATION VALVE #06-699 |
Classification | Valve, Non-rebreathing |
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 | CBP |
CFR Regulation Number | 868.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-02 |
Decision Date | 1987-11-30 |