Keratome, Battery-powered

Device Code: 4219

Product Code(s): HMY

Device Classification Information

Device Type ID4219
Device NameKeratome, Battery-powered
Regulation DescriptionKeratome.
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)
CFR Regulation Number886.4370 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHMY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID4219
DeviceKeratome, Battery-powered
Product CodeHMY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionKeratome.
CFR Regulation Number886.4370 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 20:44:59

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