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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K896151
Device Name EMISSION TOMOGRAPHY CAROUSEL
Applicant
Atf Consolidated
94 J Jefryn Blvd.
Deer Park,  NY  11729
Applicant Contact PATRICK F PANETTA
Correspondent
Atf Consolidated
94 J Jefryn Blvd.
Deer Park,  NY  11729
Correspondent Contact PATRICK F PANETTA
Regulation Number892.1200
Classification Product Code
KPS  
Date Received10/24/1989
Decision Date 04/16/1991
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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