Drape, Adhesive, Aerosol

Device Code: 2824

Product Code(s): KGT

Device Classification Information

Device Type ID2824
Device NameDrape, Adhesive, Aerosol
Regulation DescriptionDrape Adhesive.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type510(K) Exempt
CFR Regulation Number878.4380 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKGT
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2824
DeviceDrape, Adhesive, Aerosol
Product CodeKGT
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDrape Adhesive.
CFR Regulation Number878.4380 [🔎]
TPLC Last Update: 2019-04-02 20:19:21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.