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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K863286
Device Name ERS SYSTEM
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact HOWARD, II
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact HOWARD, II
Regulation Number892.2010
Classification Product Code
LMB  
Date Received08/25/1986
Decision Date 10/27/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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