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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, Stationary
510(k) Number K113248
Device Name AERODR SYSTEM WITH P-21
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 Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received11/03/2011
Decision Date 01/17/2012
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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