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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cone, Radiographic, Lead-Lined
510(k) Number K771748
Device Name INTRA ORAL X-RAY CONES
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 Number872.1850
Classification Product Code
EAH  
Date Received09/15/1977
Decision Date 09/28/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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