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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 K926206
Device Name POSICAM-HZ & POSICAM-HZL
Applicant
Positron
16350 Park Ten Pl.
Houston,  TX  77084
Applicant Contact LISA S JONES
Correspondent
Positron
16350 Park Ten Pl.
Houston,  TX  77084
Correspondent Contact LISA S JONES
Regulation Number892.1200
Classification Product Code
KPS  
Date Received12/09/1992
Decision Date 07/08/1993
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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