Drum, Eye Knife Test

Device Code: 4217

Product Code(s): HMS

Device Classification Information

Device Type ID4217
Device NameDrum, Eye Knife Test
Regulation DescriptionOphthalmic Knife Test Drum.
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 Number886.4230 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHMS
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4217
DeviceDrum, Eye Knife Test
Product CodeHMS
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOphthalmic Knife Test Drum.
CFR Regulation Number886.4230 [🔎]
TPLC Last Update: 2019-04-02 20:44:58

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