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510(k) K780391

Device
PODIATRIC MATERIAL
Applicant
CROWN DELTA CORP.
510(k) number
K780391
Product code
MNE  
Decision
Substantially Equivalent (SESE)
Decision date
1978-06-14
Date received
1978-03-10
Regulation
890.3475
Classification name
Orthosis, Moldable, Supportive, Skin Protective
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 MNE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940132PODIATRIC MATERIALCrown Delta Corp.1994-09-29

Legacy Summary#

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FDA Review#

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