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510(k) K940132

Device
PODIATRIC MATERIAL
Applicant
CROWN DELTA CORP.
510(k) number
K940132
Product code
MNE  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-29
Date received
1994-01-03
Regulation
890.3475
Classification name
Orthosis, Moldable, Supportive, Skin Protective
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LAURENCE COLIN
Address
1550 Front St. Yorktown Heights NY US 10598 10598

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
K780391PODIATRIC MATERIALCrown Delta Corp.1978-06-14

Legacy Summary#

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FDA Review#

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