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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 K002685
Device Name CORDLESS COMPACT MOBILE X-RAY SYSTEM
Applicant
MEDISON RADIOLOGY SYSTEMS, INC.
151 SOUTH PFINGSTEN RD.
DEERFIELD,,  IL  60015
Applicant Contact JOHN W LEE
Correspondent
MEDISON RADIOLOGY SYSTEMS, INC.
151 SOUTH PFINGSTEN RD.
DEERFIELD,,  IL  60015
Correspondent Contact JOHN W LEE
Regulation Number892.1720
Classification Product Code
IZL  
Date Received08/28/2000
Decision Date 09/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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