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510(k) K881331

Device
ORTHODONTIC NITINOL SPRINGS
Applicant
FLEXMEDICS
510(k) number
K881331
Product code
EJW  
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-21
Date received
1988-03-29
Regulation
872.3285
Classification name
Clasp, Wire
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SIEVERT, JR.
Address
620 Ford Ctr., 420 N. Fifth St. Minneapolis MN US 55401 55401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EJW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K901257WIRONTOM CLASP WIREIvoclar North America, Inc.1990-04-25
K872746VITALLIUM WIREAustenal Dental, Inc.1987-07-21

Legacy Summary#

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FDA Review#

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