Light, Surgical, Connector

Device Code: 5518

Product Code(s): FSX

Device Classification Information

Device Type ID5518
Device NameLight, Surgical, Connector
Regulation DescriptionSurgical Lamp.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type510(K) Exempt
CFR Regulation Number878.4580 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeFSX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID5518
DeviceLight, Surgical, Connector
Product CodeFSX
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSurgical Lamp.
CFR Regulation Number878.4580 [🔎]
TPLC Last Update: 2019-04-02 21:07:41

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