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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 K110373
Device Name TEMPOROMANIBULAR COIL 15
Applicant
Esaote, S.P.A.
Via Siffredi 58
Genova,  IT 16153
Applicant Contact DONATELLA RAGGHIANTI
Correspondent
Esaote, S.P.A.
Via Siffredi 58
Genova,  IT 16153
Correspondent Contact DONATELLA RAGGHIANTI
Regulation Number892.1000
Classification Product Code
MOS  
Date Received02/08/2011
Decision Date 04/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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