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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 K023292
Device Name APEX HRI DIGITAL RADIOGRAPHY SYSTEM
Applicant
Krugman Technologies, Inc.
1000 Hart Rd.
Suite 180
Barrington,  IL  60010
Applicant Contact MICHAEL A KRUGMAN
Correspondent
Krugman Technologies, Inc.
1000 Hart Rd.
Suite 180
Barrington,  IL  60010
Correspondent Contact MICHAEL A KRUGMAN
Regulation Number872.1800
Classification Product Code
MUH  
Date Received10/02/2002
Decision Date 12/13/2002
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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