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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K896683
Device Name COMPACT VIDEO IMAGER MP4000 SERIES III
Applicant
INTERNATIONAL IMAGING ELECTRONICS
901 S. KAY
ADDISON,  IL  60101
Applicant Contact JOHN R MIERS
Correspondent
INTERNATIONAL IMAGING ELECTRONICS
901 S. KAY
ADDISON,  IL  60101
Correspondent Contact JOHN R MIERS
Regulation Number892.2040
Classification Product Code
LMC  
Date Received11/28/1989
Decision Date 01/22/1990
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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