The following data is part of a premarket notification filed by Dr. Alan A. Lowe, Inc. with the FDA for Lowe Klearway.
| Device ID | K950763 |
| 510k Number | K950763 |
| Device Name: | LOWE KLEARWAY |
| Classification | Device, Anti-snoring |
| Applicant | DR. ALAN A. LOWE, INC. SUITE 103 2786 WEST 16TH AVENUE Vancouver, B.c. V6k 4m1, CA V6k 4m1 |
| Contact | Alan A Lowe |
| Correspondent | Alan A Lowe DR. ALAN A. LOWE, INC. SUITE 103 2786 WEST 16TH AVENUE Vancouver, B.c. V6k 4m1, CA V6k 4m1 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-17 |
| Decision Date | 1995-05-25 |