FDA.report

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
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

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

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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