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510(k) K822632

Device
ELBOW PROSTHESIS
Applicant
HOSMER DORRANCE CORP.
510(k) number
K822632
Product code
IRE  
Decision
Substantially Equivalent (SESE)
Decision date
1982-09-14
Date received
1982-08-31
Regulation
890.3420
Classification name
Joint, Elbow, External Limb Component, Powered
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IRE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K802642UTAH ARTIFICAL ARMMotion Control, Inc.1980-11-12

Legacy Summary#

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FDA Review#

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