Block, Cutting, Ent, Sterile

Device Code: 1485

Product Code(s): JXS

Device Classification Information

Device Type ID1485
Device NameBlock, Cutting, Ent, Sterile
Regulation DescriptionProsthesis Modification Instrument For Ossicular Replacement Surgery.
Regulation Medical SpecialtyEar Nose & Throat
Review PanelEar Nose & Throat
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Ear, Nose, And Throat Devices Branch (ENTB)
Submission Type510(K) Exempt
CFR Regulation Number874.3540 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJXS
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1485
DeviceBlock, Cutting, Ent, Sterile
Product CodeJXS
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionProsthesis Modification Instrument For Ossicular Replacement Surgery.
CFR Regulation Number874.3540 [🔎]
TPLC Last Update: 2019-04-02 19:54:47

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