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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 K081637
Device Name LASER IMAGER DRYPRO MODEL 873
Applicant
Konica Minolta Medical & Graphic, Inc.
140 E. 45th St., 25th Floor
Two Grand Central Tower
New York,  NY  10017
Applicant Contact RUSSELL MUNVES
Correspondent
Konica Minolta Medical & Graphic, Inc.
140 E. 45th St., 25th Floor
Two Grand Central Tower
New York,  NY  10017
Correspondent Contact RUSSELL MUNVES
Regulation Number892.2040
Classification Product Code
LMC  
Date Received06/11/2008
Decision Date 07/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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