Applicator, Ent

Device Code: 1572

Product Code(s): KCJ

Device Classification Information

Device Type ID1572
Device NameApplicator, Ent
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 CodeKCJ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1572
DeviceApplicator, Ent
Product CodeKCJ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEar, Nose, And Throat Drug Administration Device.
CFR Regulation Number874.5220 [🔎]
Device Problems
Break
1
Tip
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 19:56:01

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