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IRE — Joint, Elbow, External Limb Component, Powered Class I

FDA Device Classification

Classification Details

Product Code
IRE
Device Class
Class I
Regulation Number
890.3420
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K822632hosmer dorranceELBOW PROSTHESISSeptember 14, 1982
K802642motion controlUTAH ARTIFICAL ARMNovember 12, 1980