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510(k) K823152

Device
OB HELP ARM
Applicant
ORTHION CORP.
510(k) number
K823152
Product code
ILE  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-05
Date received
1982-10-20
Regulation
890.3475
Classification name
Sling, Arm, Overhead Supported
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 ILE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K830842OB HELP ARMLic-Orthion1983-04-05
K823811OVERHEAD ARM SLINGSDanek Medical, Inc.1983-01-14

Legacy Summary#

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FDA Review#

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