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510(k) K822198

Device
MALLEUS NIPPERS
Applicant
KELLEHER CORP.
510(k) number
K822198
Product code
JEK  
Decision
Substantially Equivalent (SESE)
Decision date
1982-08-25
Date received
1982-07-23
Regulation
874.4680
Classification name
Forceps, Biopsy, Bronchoscope (rigid)
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
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 JEK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K990561OPTICAL FORCEPSPilling Weck Surgical1999-05-14
K822193FORCEPS FOR USE WITH RIGID ENDOSCOPESKelleher Corp.1982-08-24

Legacy Summary#

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FDA Review#

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