Clip, Tantalum, Ophthalmic

Device Code: 4308

Product Code(s): HQW

Device Classification Information

Device Type ID4308
Device NameClip, Tantalum, Ophthalmic
Regulation DescriptionOphthalmic Tantalum Clip.
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 Number886.3100 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHQW
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4308
DeviceClip, Tantalum, Ophthalmic
Product CodeHQW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionOphthalmic Tantalum Clip.
CFR Regulation Number886.3100 [🔎]
TPLC Last Update: 2019-04-02 20:46:44

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