Support, Head, Surgical, Ent

Device Code: 5496

Product Code(s): EPW

Device Classification Information

Device Type ID5496
Device NameSupport, Head, Surgical, Ent
Regulation DescriptionManual Operating Table And Accessories And Manual Operating Chair And Accessories.
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 Number878.4950 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEPW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5496
DeviceSupport, Head, Surgical, Ent
Product CodeEPW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Operating Table And Accessories And Manual Operating Chair And Accessories.
CFR Regulation Number878.4950 [🔎]
TPLC Last Update: 2019-04-02 21:07:13

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