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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 K031802
Device Name CORIX 70 PLUS-USV
Applicant
Coramex, S.A.
251 E. Dundee Rd. Suite #6
Wheeling,  IL  60090
Applicant Contact AL SOSA
Correspondent
Coramex, S.A.
251 E. Dundee Rd. Suite #6
Wheeling,  IL  60090
Correspondent Contact AL SOSA
Regulation Number872.1800
Classification Product Code
EHD  
Date Received06/11/2003
Decision Date 07/21/2003
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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