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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 K013381
Device Name ADVANCED LUNG ANALYSIS-1
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact STEVEN J KACHELMEYER
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact WOLFRAM GMELIN
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/12/2001
Decision Date 10/26/2001
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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