Apron, Leaded

Device Code: 5269

Product Code(s): EAJ

Device Classification Information

Device Type ID5269
Device NameApron, Leaded
Regulation DescriptionPersonnel Protective Shield.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.6500 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEAJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5269
DeviceApron, Leaded
Product CodeEAJ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPersonnel Protective Shield.
CFR Regulation Number892.6500 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Contour Fabricators Inc
II Oct-13-2016
TPLC Last Update: 2019-04-02 21:03:24

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