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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, Fluoroscopic, Image-Intensified
510(k) Number K972442
Device Name CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002
Applicant
Continental X-Ray Corp.
2000 S. 25th Ave.
Broadview,  IL  60153
Applicant Contact OSCAR KHUTORYANSKY
Correspondent
Continental X-Ray Corp.
2000 S. 25th Ave.
Broadview,  IL  60153
Correspondent Contact OSCAR KHUTORYANSKY
Regulation Number892.1650
Classification Product Code
JAA  
Date Received06/30/1997
Decision Date 09/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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