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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 K760466
Device Name TABLE, X-RAY, RFX CLASSICAL
Applicant
General Electric Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
General Electric Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1980
Classification Product Code
IXR  
Date Received08/18/1976
Decision Date 08/26/1976
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
Recalls CDRH Recalls
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