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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K061999
Device Name DRY LASER IMAGER, DRYPRO MODEL 832
Applicant
Konica Minolta Medical & Graphic, Inc.
2970 Ishikawa-Machi
Hachioji-Shi,  JP 192-8505
Applicant Contact JOJI MATSUSHIMA
Correspondent
Konica Minolta Medical & Graphic, Inc.
2970 Ishikawa-Machi
Hachioji-Shi,  JP 192-8505
Correspondent Contact JOJI MATSUSHIMA
Regulation Number892.2040
Classification Product Code
LMC  
Date Received07/14/2006
Decision Date 08/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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