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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K041937
Device Name RESTITU
Applicant
Resonant Medical, Inc.
16787 Bernardo Center Dr.,
Suite A-1
San Diego,  CA  92128
Applicant Contact SEAN M CURRY
Correspondent
Resonant Medical, Inc.
16787 Bernardo Center Dr.,
Suite A-1
San Diego,  CA  92128
Correspondent Contact SEAN M CURRY
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Codes
IWB   KPQ  
Date Received07/19/2004
Decision Date 11/16/2004
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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