The following data is part of a premarket notification filed by Firma Ingemarsson with the FDA for Noiselezz.
Device ID | K160531 |
510k Number | K160531 |
Device Name: | Noiselezz |
Classification | Device, Anti-snoring |
Applicant | FIRMA INGEMARSSON VILVORDEVEJ 61 Charlottenlund, DK 2920 |
Contact | Natashia Ingemarsson-matzen |
Correspondent | Poul Schmidt-andersen DANISH MEDICAL DEVICES CONSULTING APS DOKTOR MUNDTSVEJ 9B Farum, DK 3520 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-25 |
Decision Date | 2016-09-01 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() NOISELEZZ 87444170 5476981 Live/Registered |
Petruska, LLC 2017-05-10 |