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510(k) K780763

Device
ENTRAX TRACTION UNIT
Applicant
ORTHOPEDIC EQUIPMENT CO., INC.
510(k) number
K780763
Product code
HSR  
Decision
Substantially Equivalent (SESE)
Decision date
1978-05-16
Date received
1978-05-08
Regulation
888.5890
Classification name
Unit, Traction, Hip, Non-powered, Non-penetrating
Medical specialty
Orthopedic
Review panel
Orthopedic
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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