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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name table, radiologic
510(k) Number K790692
Device Name TELEVIX
Applicant
GENERAL ELECTRICAL ESPANOLA, S.A.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
GENERAL ELECTRICAL ESPANOLA, S.A.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number892.1980
Classification Product Code
KXJ  
Date Received04/10/1979
Decision Date 04/23/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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