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U.S. Department of Health and Human Services

Product Classification

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Device cream, nasal, topical, mechanical allergen particle barrier
Regulation Description Medical recirculating air cleaner.
Definition The device is intended to promote alleviation of mild allergic symptoms triggered by the inhalation of various allergens.
Regulation Medical Specialty General Hospital
Review Panel Ear Nose & Throat
Product CodeNUP
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 880.5045
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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