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510(k) K843901

Device
ISOSTATIC CONDENSER
Applicant
SHOFU DENTAL CORP.
510(k) number
K843901
Product code
EKG  
Decision
Substantially Equivalent (SESE)
Decision date
1984-12-03
Date received
1984-10-03
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
ROBERT MANDLER
Address
4024 Bohannon Dr. Menlo Park CA US 94025 94025

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
K865025AUSTENAL CONDENSING INSTRUMENTAustenal Dental, Inc.1987-02-19
K823322DENTAL INSTRUMENTS - PLUGGERSMiltex, Inc.1982-11-24

Legacy Summary#

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FDA Review#

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