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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 Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Ear, Nose, and Throat Devices Branch (ENTB)
Submission Type 510(k)
Regulation Number 872.5570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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