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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name digitizer, image, radiological
510(k) Number K013395
Device Name LIFEJET VIDEO LINK
Applicant
FERRANIA S.P.A.
57 VIALE DELLA LIBERTA
FERRANIA, SAVONA,  IT 17014
Applicant Contact ING. MANNELLA PAOLO
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact CHANTEL CARSON
Regulation Number892.2030
Classification Product Code
LMA  
Date Received10/15/2001
Decision Date 10/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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