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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K760201
Device Name X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC
Applicant
American Science and Engineering, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Science and Engineering, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/08/1976
Decision Date 10/05/1976
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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