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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K121249
Device Name MULTIARRAY KIT
Applicant
Paramed S.R.L.
Corso Perrone 73r
Genova,  IT 16152
Applicant Contact LUISELLA DE BENEDETTI
Correspondent
Paramed S.R.L.
Corso Perrone 73r
Genova,  IT 16152
Correspondent Contact LUISELLA DE BENEDETTI
Regulation Number892.1000
Classification Product Code
MOS  
Date Received04/25/2012
Decision Date 06/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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