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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K831412
Device Name CRM-100 COLOR VIDEO CAMERA
Applicant
UMI, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
UMI, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1500
Classification Product Code
FET  
Date Received05/02/1983
Decision Date 06/03/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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