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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiologic
510(k) Number K862144
Device Name X-MAT
Applicant
Combined Concepts, Inc.
927 Southwest 118th Ct.
Miami,  FL  33184
Applicant Contact COHEN, PHD
Correspondent
Combined Concepts, Inc.
927 Southwest 118th Ct.
Miami,  FL  33184
Correspondent Contact COHEN, PHD
Regulation Number892.1980
Classification Product Code
KXJ  
Date Received06/04/1986
Decision Date 06/25/1986
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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