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510(k) K932675

Device
GXP DENTAL X-RAY PROCESSOR
Applicant
GENDEX CORP.
510(k) number
K932675
Product code
EGN  
Decision
Substantially Equivalent (SESE)
Decision date
1993-07-26
Date received
1993-06-02
Regulation
872.4565
Classification name
Scissors, Surgical Tissue, Dental
Medical specialty
Dental
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JAMES E KETTNER
Address
901 W. Oakton St. Des Plaines IL US 60018 60018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EGN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K8517201155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORSArtiberia1985-07-02
K821275MAYO SCISSOR STRAIGHT 5 1/2Conphar, Inc.1982-05-28
K821276MAYO SCISSOR CURYED 5 1/2Conphar, Inc.1982-05-28
K821292TONSIL SCISSORS 7Conphar, Inc.1982-05-28
K821294TONSIL SCISSORS STRAIGHT 5 1/2Conphar, Inc.1982-05-28
K821077CONPHARConphar, Inc.1982-05-24

Legacy Summary#

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FDA Review#

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