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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 K043104
Device Name KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0
Applicant
Practiceworks, Inc.
1765 The Exchange
Atlanta,  GA  30339
Applicant Contact DANIEL HOEFER
Correspondent
Practiceworks, Inc.
1765 The Exchange
Atlanta,  GA  30339
Correspondent Contact DANIEL HOEFER
Regulation Number872.1800
Classification Product Code
EHD  
Date Received11/09/2004
Decision Date 02/24/2005
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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