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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 K852239
Device Name POSICAM TM(MODEL 3.2,4.3,6.5)
Applicant
Position Corp.
P.O. Box 16598
Wedgewood Station
Fort Worth,  TX  76162
Applicant Contact RICHARD A HAMER
Correspondent
Position Corp.
P.O. Box 16598
Wedgewood Station
Fort Worth,  TX  76162
Correspondent Contact RICHARD A HAMER
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/23/1985
Decision Date 09/03/1985
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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