The following data is part of a premarket notification filed by Great Lakes Orthodontics, Ltd. with the FDA for Snore-no-more.
| Device ID | K922818 |
| 510k Number | K922818 |
| Device Name: | SNORE-NO-MORE |
| Classification | Device, Jaw Repositioning |
| Applicant | GREAT LAKES ORTHODONTICS, LTD. 199 FIRE TOWER DR. P.O. BOX 5111 Tonawanda, NY 14151 -5111 |
| Contact | James R Kunkemoller |
| Correspondent | James R Kunkemoller GREAT LAKES ORTHODONTICS, LTD. 199 FIRE TOWER DR. P.O. BOX 5111 Tonawanda, NY 14151 -5111 |
| Product Code | LQZ |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-11 |
| Decision Date | 1994-02-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SNORE-NO-MORE 74239773 not registered Dead/Abandoned |
PROBELLE, INC. 1992-01-24 |
![]() SNORE-NO-MORE 73784574 1579053 Dead/Cancelled |
HUDSON INDUSTRIES INC. 1989-03-06 |