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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 K953165
Device Name ULTRA COMPACT VIDEO IMAGER
Applicant
INTERNATIONAL IMAGING ELECTRONICS
881 REMINGTON BLVD.
BOLINGBROOK,  IL  60440 -4932
Applicant Contact ROGER CLAAR
Correspondent
INTERNATIONAL IMAGING ELECTRONICS
881 REMINGTON BLVD.
BOLINGBROOK,  IL  60440 -4932
Correspondent Contact ROGER CLAAR
Regulation Number892.2040
Classification Product Code
LMC  
Date Received07/07/1995
Decision Date 05/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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