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510(k) K970930

Device
BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE
Applicant
Cleft Palate Appliances, Inc.
510(k) number
K970930
Product code
DYJ
Decision
Substantially Equivalent (SESE)
Decision date
1997-04-23
Date received
1997-03-13
Regulation
872.5410
Classification name
Retainer, Screw Expansion, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ELIZABETH ANN LATHAM
Address
218 Commisioners Rd., W. London CA N6J 1Y1 N6J 1Y1

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DYJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K935154DENTAURUM EXPANSION SCREWSDentauraum, Inc.1994-02-03
K925088EXPANSION SCREWSForestadent1993-05-22
K912417MOLAR DISTALIZING ASSEMBLYAmerican Orthodontics1991-12-20
K843705MANDIBULATOR JAW POSITIONERA Company, Inc.1984-11-14