Weights, Eyelid, External

Device Code: 4348

Product Code(s): MML

Device Classification Information

Device Type ID4348
Device NameWeights, Eyelid, External
Regulation DescriptionEyelid Weight.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Intraocular And Corneal Implants Devices Branch (ICIB)
Submission Type510(k)
CFR Regulation Number886.5700 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMML
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4348
DeviceWeights, Eyelid, External
Product CodeMML
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEyelid Weight.
CFR Regulation Number886.5700 [🔎]
TPLC Last Update: 2019-04-02 20:47:25

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