Crutch, Ptosis

Device Code: 4162

Product Code(s): HJZ

Device Classification Information

Device Type ID4162
Device NameCrutch, Ptosis
Regulation DescriptionPtosis Crutch.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Diagnostic And Surgical Devices Branch (DSDB)
Submission Type510(K) Exempt
CFR Regulation Number886.5600 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHJZ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4162
DeviceCrutch, Ptosis
Product CodeHJZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPtosis Crutch.
CFR Regulation Number886.5600 [🔎]
TPLC Last Update: 2019-04-02 20:44:01

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