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510(k) K844034

Device
SONOCARE
Applicant
ECHO ULTRASOUND
510(k) number
K844034
Product code
DYO  
Decision
Substantially Equivalent (SESE)
Decision date
1985-01-23
Date received
1984-10-16
Regulation
872.5410
Classification name
Band, Material, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
FRANK L SAYLOR
Address
Post Office Box 552 Lewistown PA US 17044 17044

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DYO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K935152DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARDDentauraum, Inc.1994-01-31
K931980STAINLESS STEEL ORTHODONTIC PRODUCTSOrtho Organizers, Inc.1993-09-01

Legacy Summary#

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FDA Review#

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