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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 K043307
Device Name CRANEX D
Applicant
Soredex Palodex Group OY
Nahkelantie 160
Tuusula,  FI 00430
Applicant Contact KAI LANER
Correspondent
Soredex Palodex Group OY
Nahkelantie 160
Tuusula,  FI 00430
Correspondent Contact KAI LANER
Regulation Number872.1800
Classification Product Code
EHD  
Date Received12/01/2004
Decision Date 12/17/2004
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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