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U.S. Department of Health and Human Services

Product Classification

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Device pillow, cervical (for mild sleep apnea)
Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
Regulation Medical Specialty Dental
Review Panel Ear Nose & Throat
Product CodeMYB
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 872.5570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons
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