FDA.reportPublic FDA data

510(k) K160477

Device
The Luco Hybrid OSA Appliance
Applicant
LUCO HYBRID OSA APPLIANCE INC.
510(k) number
K160477
Product code
OCO  
Decision
Substantially Equivalent (SESE)
Decision date
2016-07-29
Date received
2016-02-19
Regulation
510(k) Premarket Notification
Classification name
Mouthguard, Migraine/tension Headache
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Dental
Device class
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Ken Luco
Address
1419 Butternut Creek Rd. Kingston CA K7L 4V3 K7L 4V3

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code OCO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202523TMJ RelaxMoonwalker Innovations, Inc.2021-06-24
K010876NTI TENSION SUPPRESSION SYSTEMNti-Tss, Inc.2001-06-20

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases