Implant, Absorbable, (scleral Buckling Methods)

Device Code: 4298

Product Code(s): HQJ

Device Classification Information

Device Type ID4298
Device NameImplant, Absorbable, (scleral Buckling Methods)
Regulation DescriptionAbsorbable Implant (scleral Buckling Method).
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)
CFR Regulation Number886.3300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHQJ
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4298
DeviceImplant, Absorbable, (scleral Buckling Methods)
Product CodeHQJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAbsorbable Implant (scleral Buckling Method).
CFR Regulation Number886.3300 [🔎]
TPLC Last Update: 2019-04-02 20:46:28

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