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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K030420
Device Name LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
Applicant
GE MEDICAL SYSTEMS
3000 NORTH GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact JOHN W JAECKLE
Correspondent
GE MEDICAL SYSTEMS
3000 NORTH GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact JOHN W JAECKLE
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/10/2003
Decision Date 03/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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