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 |