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510(k) K990561

Device
OPTICAL FORCEPS
Applicant
PILLING WECK SURGICAL
510(k) number
K990561
Product code
JEK  
Decision
Substantially Equivalent (SESE)
Decision date
1999-05-14
Date received
1999-02-22
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
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ELIZABETH LAZARO
Address
420 Delaware Dr. Fort Washington PA US 19034 19034

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JEK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K822198MALLEUS NIPPERSKelleher Corp.1982-08-25
K822193FORCEPS FOR USE WITH RIGID ENDOSCOPESKelleher Corp.1982-08-24

Legacy Summary#

summary

FDA Review#

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