Device, Finger-sucking

Device Code: 1394

Product Code(s): LQX

Device Classification Information

Device Type ID1394
Device NameDevice, Finger-sucking
Regulation DescriptionLimb Orthosis.
Regulation Medical SpecialtyPhysical Medicine
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(K) Exempt
CFR Regulation Number890.3475 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeLQX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1394
DeviceDevice, Finger-sucking
Product CodeLQX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLimb Orthosis.
CFR Regulation Number890.3475 [🔎]
TPLC Last Update: 2019-04-02 19:53:22

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