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510(k) K802911

Device
A/K SOCKET
Applicant
ORTHOMEDICS
510(k) number
K802911
Product code
ISS  
Decision
Substantially Equivalent (SESE)
Decision date
1980-12-17
Date received
1980-11-17
Regulation
890.3420
Classification name
Prosthesis, Thigh Socket, External Component
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

Legacy Summary#

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FDA Review#

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