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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Grid, Radiographic
510(k) Number K941626
Device Name GRIDGIL
Applicant
Gilardoni S.P.A.
2, Via Fermi
Mandello Lario,  IT 22054
Applicant Contact CRISTINA GILARDONI
Correspondent
Gilardoni S.P.A.
2, Via Fermi
Mandello Lario,  IT 22054
Correspondent Contact CRISTINA GILARDONI
Regulation Number892.1910
Classification Product Code
IXJ  
Date Received04/04/1994
Decision Date 05/13/1994
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
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