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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K992392
Device Name RTLX
Applicant
Infimed, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Applicant Contact RALPH FLATAU
Correspondent
Infimed, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Correspondent Contact RALPH FLATAU
Regulation Number872.1800
Classification Product Code
MUH  
Date Received07/19/1999
Decision Date 03/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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