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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, Mobile
510(k) Number K911841
Device Name MINXRAY P300 X-RAY SYSTEM
Applicant
Minxray, Inc.
3611 Commercial Ave.
Northbrook,  IL  60062
Applicant Contact KEITH R KRETCHMER
Correspondent
Minxray, Inc.
3611 Commercial Ave.
Northbrook,  IL  60062
Correspondent Contact KEITH R KRETCHMER
Regulation Number892.1720
Classification Product Code
IZL  
Date Received04/25/1991
Decision Date 08/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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