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510(k) K861298

Device
FISCH DRILL IRRIGATOR
Applicant
JEDMED INSTRUMENT CO.
510(k) number
K861298
Product code
KAR  
Decision
Substantially Equivalent (SESE)
Decision date
1986-04-23
Date received
1986-04-07
Regulation
874.4420
Classification name
Irrigator, Sinus
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CRAIG RAPP
Address
1430 Hanley Industrial Ct. St. Louis MO US 63144 63144

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KAR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K131177SINUFLUSH LAVAGE SYSTEMHedgepath, LLC2013-09-20
K931398GM SWIVEL VIDEO (TM) IRRIGATORGm Engineering, Inc.1993-08-30

Legacy Summary#

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FDA Review#

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