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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 K890486
Device Name MXR-14 FILM PROCESSOR
Applicant
Cordell, Inc.
Six Centennial Dr.
Peabody,  MA  01960
Applicant Contact RICHARD C REEDY
Correspondent
Cordell, Inc.
Six Centennial Dr.
Peabody,  MA  01960
Correspondent Contact RICHARD C REEDY
Regulation Number892.1900
Classification Product Code
IXW  
Date Received01/31/1989
Decision Date 04/03/1990
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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