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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K833525
Device Name CEMAX-1000
Applicant
Contour Medical Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Contour Medical Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.2010
Classification Product Code
LMB  
Date Received09/22/1983
Decision Date 11/21/1983
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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