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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cephalometer
510(k) Number K920189
Device Name GX-C CEPHALOMETER
Applicant
Gendex Corp.
901 W. Oakton St.
Des Plaines,  IL  60018
Applicant Contact GERALD LLEVY
Correspondent
Gendex Corp.
901 W. Oakton St.
Des Plaines,  IL  60018
Correspondent Contact GERALD LLEVY
Regulation Number872.1830
Classification Product Code
EAG  
Date Received01/15/1992
Decision Date 04/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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