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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 K993896
Device Name MCA-601, C-ARM MOBILE
Applicant
Medison Radiology Systems, Inc.
2000 Lehigh Ave.
Glenview,  IL  60025
Applicant Contact JOHN W LEE
Correspondent
Medison Radiology Systems, Inc.
2000 Lehigh Ave.
Glenview,  IL  60025
Correspondent Contact JOHN W LEE
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
IZL  
Date Received11/16/1999
Decision Date 03/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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