Ring, Ophthalmic (flieringa)

Device Code: 4228

Product Code(s): HNH

Device Classification Information

Device Type ID4228
Device NameRing, Ophthalmic (flieringa)
Regulation DescriptionManual Ophthalmic Surgical Instrument.
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) Exempt
CFR Regulation Number886.4350 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHNH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4228
DeviceRing, Ophthalmic (flieringa)
Product CodeHNH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Ophthalmic Surgical Instrument.
CFR Regulation Number886.4350 [🔎]
Device Problems
Device Contamination With Chemical Or Other Material
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 20:45:09

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