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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 K912400
Device Name MOBILE X-RAY FLOOR STAND
Applicant
Dntl Corp.
12742 E. Caley Ave.
Englewood,  CO  80111
Applicant Contact ROBERT GIVAN
Correspondent
Dntl Corp.
12742 E. Caley Ave.
Englewood,  CO  80111
Correspondent Contact ROBERT GIVAN
Regulation Number892.1720
Classification Product Code
IZL  
Date Received05/30/1991
Decision Date 08/09/1991
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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