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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 K081105
Device Name GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
Applicant
GE HEALTHCARE
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact ANDREW MENDEN
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/18/2008
Decision Date 05/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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