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510(k) K202523

Device
TMJ Relax
Applicant
Moonwalker Innovations Inc
510(k) number
K202523
Product code
OCO  
Decision
Substantially Equivalent (SESE)
Decision date
2021-06-24
Date received
2020-09-01
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
Charles Sutera
Address
20 Roosevelt Rd. Medford MA US 02155 02155

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OCO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K160477The Luco Hybrid OSA ApplianceLuco Hybrid Osa Appliance, Inc.2016-07-29
K010876NTI TENSION SUPPRESSION SYSTEMNti-Tss, Inc.2001-06-20

Legacy Summary#

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FDA Review#

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