Inhaler, Nasal

Device Code: 1576

Product Code(s): KCO

Device Classification Information

Device Type ID1576
Device NameInhaler, Nasal
Regulation DescriptionEar, Nose, And Throat Drug Administration Device.
Regulation Medical SpecialtyEar Nose & Throat
Review PanelEar Nose & Throat
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 Type510(K) Exempt
CFR Regulation Number874.5220 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKCO
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1576
DeviceInhaler, Nasal
Product CodeKCO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEar, Nose, And Throat Drug Administration Device.
CFR Regulation Number874.5220 [🔎]
TPLC Last Update: 2019-04-02 19:56:04

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