S. Dr. Alan A. Lowe Inc. / SomnoMed Ltd. / Frantz Design Inc. / Deanna L. Baxam Baxam Law Group Limited Liability Company / K1 13516 Trade / Jonathan A. Parker D.D. / Family Dental Services / Thomas E. Meade D.D. / /
Event
FDA Phase / /
Facility
General Hospital / New Hampshire Avenue Document Control Center / /
IndustryTerm
metal / plastics / stainless steel / adjustable intraoral device / announcements concerning your device / predicate devices / anti-snoring device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / stainless steel tension springs / Internet address http /
MedicalCondition
Obstructive Sleep Apnea / tooth mobility / /
Organization
Division of Postmarket Surveillance / Food and Drug Administration / M.B.A. Director Division of Anesthesiology / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / General Hospital / Respiratory / Infection Control and Dental Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / /
Person
Susan Runner / Anthony D. Watson / / /
Position
dentist / Device Trade Name Manufacturer Myerson EMA Adjustable PM / Adjustable PM / physician / /
JN0421 510(k) Summary This summary of substantial equivalence for the purposes of assessing safety and effectiveness under Section 5 10(k) of the Federal Food, Drug, and Cosmetic Act is being submitted in