Strip, Adhesive, Closure, Skin

Device Code: 5466

Product Code(s): FPX

Device Classification Information

Device Type ID5466
Device NameStrip, Adhesive, Closure, Skin
Regulation DescriptionMedical Adhesive Tape And Adhesive Bandage.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(k)
CFR Regulation Number880.5240 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFPX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5466
DeviceStrip, Adhesive, Closure, Skin
Product CodeFPX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMedical Adhesive Tape And Adhesive Bandage.
CFR Regulation Number880.5240 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
2
Total Device Problems 2
TPLC Last Update: 2019-04-02 21:06:44

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