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510(k) K865025

Device
AUSTENAL CONDENSING INSTRUMENT
Applicant
AUSTENAL DENTAL, INC.
510(k) number
K865025
Product code
EKG  
Decision
Substantially Equivalent (SESE)
Decision date
1987-02-19
Date received
1986-12-23
Regulation
872.4565
Classification name
Condenser, Amalgam And Foil, Operative
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHAN HULTEN
Address
5101 S. Keeler Ave. Chicago IL US 60632 60632

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EKG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K843901ISOSTATIC CONDENSERShofu Dental Corp.1984-12-03
K823322DENTAL INSTRUMENTS - PLUGGERSMiltex, Inc.1982-11-24

Legacy Summary#

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FDA Review#

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