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510(k) K823914

Device
EXPLORER TIP
Applicant
TREACE MEDICAL, INC.
510(k) number
K823914
Product code
EKB  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-21
Date received
1982-12-28
Regulation
872.4565
Classification name
Explorer, Operative
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EKB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K8517241410/1 TO 1435/13 VARIOUS PROBES & EXPLORERSArtiberia1985-07-02
K821780BEACH EXPLORER NO. 23T.G.Pacific Dental Corp.1982-07-06

Legacy Summary#

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FDA Review#

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