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510(k) K780719

Device
FUNGUS FIGHTER INSOLES
Applicant
COMBE, INC.
510(k) number
K780719
Product code
KYS  
Decision
Substantially Equivalent (SESE)
Decision date
1978-10-10
Date received
1978-05-01
Regulation
880.6280
Classification name
Insoles, Medical
Medical specialty
General Hospital
Review panel
General Hospital
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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