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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Tilting
510(k) Number K882019
Device Name SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact KROGER, PHD
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact KROGER, PHD
Regulation Number892.1980
Classification Product Code
IXR  
Date Received05/13/1988
Decision Date 05/31/1988
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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