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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K924430
Device Name AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027
Applicant
Alphatek Corp.
Post Office Box 5571
Chicago,  IL  60680
Applicant Contact PAUL M KUPSCO
Correspondent
Alphatek Corp.
Post Office Box 5571
Chicago,  IL  60680
Correspondent Contact PAUL M KUPSCO
Regulation Number892.1900
Classification Product Code
IXW  
Date Received09/01/1992
Decision Date 11/27/1992
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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