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510(k) K821639

Device
ANKLE FOOT ORTHOSIS
Applicant
FRED SAMMONS, INC.
510(k) number
K821639
Product code
ITW  
Decision
Substantially Equivalent (SESE)
Decision date
1982-06-11
Date received
1982-06-03
Regulation
890.3475
Classification name
Joint, Ankle, External Brace
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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