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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, Intraoral
510(k) Number K950667
Device Name AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER
Applicant
Chicago X-Ray Systems, Inc.
219 Mayer Ave.
Wheeling,  IL  60090
Applicant Contact AL SOSA
Correspondent
Chicago X-Ray Systems, Inc.
219 Mayer Ave.
Wheeling,  IL  60090
Correspondent Contact AL SOSA
Regulation Number872.1810
Classification Product Code
EAP  
Date Received02/13/1995
Decision Date 04/06/1995
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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