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510(k) K942492

Device
ADJUSTABLE BITE CORRECTOR
Applicant
ORTHOPLUS, INC.
510(k) number
K942492
Product code
ECO  
Decision
Substantially Equivalent (SESE)
Decision date
1994-07-13
Date received
1994-05-25
Regulation
872.5410
Classification name
Spring, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVID LEE
Address
1275 Fourth St., Suite 381 Santa Rosa CA US 95404 95404

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ECO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943068MAGNEFORCEOrmco Corp.1994-08-17
K933542MESIAL LOOP BARGac Intl., Inc.1994-08-05
K844234ACTIVE VERTICAL CORRECTOR APPLIANCEActive Vertical Correctors, Inc.1985-01-04
K843550ORTHOMAG MAGNETIC FORCE SYSTEMMedical Magnetics, Inc.1984-12-21
K843344ACTIVE VERTICAL CORRECTOR ACTIVE BITEActive Vertical Correctors, Inc.1984-12-03
K770558ISODYNEHmw Industries1977-04-05

Legacy Summary#

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FDA Review#

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