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510(k) K822568

Device
EAR PROBES
Applicant
KELLEHER CORP.
510(k) number
K822568
Product code
EKL  
Decision
Substantially Equivalent (SESE)
Decision date
1982-09-14
Date received
1982-08-24
Regulation
872.3840
Classification name
Point, Silver, Endodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EKL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K992582PACIFIC IMPLANT TITANIUM ENDODONTIC POINTPacific Implant, Inc.1999-10-21
K961089PULPDENT ENDOPREP IIPulpdent Corp.1996-04-23

Legacy Summary#

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FDA Review#

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