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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 K022001
Device Name MPOWER, MODEL 712 SERIES
Applicant
Positron Corp.
1304 Langham Creek Dr., #300
Houston,  TX  77084
Applicant Contact IRENE C ALBRIGHT
Correspondent
Positron Corp.
1304 Langham Creek Dr., #300
Houston,  TX  77084
Correspondent Contact IRENE C ALBRIGHT
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/19/2002
Decision Date 07/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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