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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K043136
Device Name ELITY 70 X-RAY
Applicant
Dental X-Ray E.U.
1460 NW 107 Ave. Suite G
Miami,  FL  33172
Applicant Contact GEORGE ECHEVERRI
Correspondent
Dental X-Ray E.U.
1460 NW 107 Ave. Suite G
Miami,  FL  33172
Correspondent Contact GEORGE ECHEVERRI
Regulation Number872.1800
Classification Product Code
EHD  
Date Received11/12/2004
Decision Date 01/06/2005
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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