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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 K945707
Device Name MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT
Applicant
Minxray, Inc.
3611 Commercial Ave.
Northbrook,  IL  60062
Applicant Contact EITH R KRETCHMER
Correspondent
Minxray, Inc.
3611 Commercial Ave.
Northbrook,  IL  60062
Correspondent Contact EITH R KRETCHMER
Regulation Number892.1720
Classification Product Code
IZL  
Date Received11/21/1994
Decision Date 01/19/1995
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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