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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K790499
Device Name MULTIPLE PINHOLE TOMOGRAPHIC COLLIMOTER
Applicant
Engineering Dynamics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Engineering Dynamics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1100
Classification Product Code
IYX  
Date Received03/13/1979
Decision Date 03/26/1979
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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