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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 K911275
Device Name POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM
Applicant
Positron
8080 El Rio
Houston,  TX  77054
Applicant Contact RICHARD E HITCHENS
Correspondent
Positron
8080 El Rio
Houston,  TX  77054
Correspondent Contact RICHARD E HITCHENS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/22/1991
Decision Date 05/09/1991
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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