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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Mount, X-Ray, Diagnostic
510(k) Number K911563
Device Name INVENTOR RT/EXPLORER TRAUMA UNIT
Applicant
Continental X-Ray Corp.
2000 S. 25th Ave.
Broadview,  IL  60153
Applicant Contact JAMES M TAYLOR
Correspondent
Continental X-Ray Corp.
2000 S. 25th Ave.
Broadview,  IL  60153
Correspondent Contact JAMES M TAYLOR
Regulation Number892.1770
Classification Product Code
IYB  
Date Received04/08/1991
Decision Date 10/23/1991
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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