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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 K021054
Device Name CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER
Applicant
CODONICS, INC.
17991 ENGLEWOOD DR.
MIDDLEBURG HEIGHTS,  OH  44130
Applicant Contact RICK DAYTON
Correspondent
CODONICS, INC.
17991 ENGLEWOOD DR.
MIDDLEBURG HEIGHTS,  OH  44130
Correspondent Contact RICK DAYTON
Regulation Number892.2040
Classification Product Code
LMC  
Date Received04/01/2002
Decision Date 05/09/2002
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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