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510(k) K931980

Device
STAINLESS STEEL ORTHODONTIC PRODUCTS
Applicant
ORTHO ORGANIZERS, INC.
510(k) number
K931980
Product code
DYO  
Decision
Substantially Equivalent (SESE)
Decision date
1993-09-01
Date received
1993-04-22
Regulation
872.5410
Classification name
Band, Material, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHUCK TYRRELL
Address
1619 S. Rancho Santa Fe Rd. San Marcos CA US 92069 92069

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K844034SONOCAREEcho Ultrasound1985-01-23

Legacy Summary#

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FDA Review#

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