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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K011617
Device Name LIFEJET PRINTER 400
Applicant
Ferrania S.P.A. Stabilimento DI Ferrania
57 Viale Della Liberta
Ferrania, Savona,  IT 17014
Applicant Contact RICCARDO GENTA
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact CHANTEL CARSON
Regulation Number892.2040
Classification Product Code
LMC  
Date Received05/25/2001
Decision Date 06/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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