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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 K023932
Device Name GE PHOTON ENERGY RECOVERY (PER) OPTION
Applicant
Ge Medical Systems F.I. Haifa
4 Hayozma St. P.O. Box 170
Tirat Hacarmel,  IL 30200
Applicant Contact HEMY NEUMAN
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Regulation Number892.1200
Classification Product Code
KPS  
Date Received11/26/2002
Decision Date 12/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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