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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transcranial Magnetic Stimulator
510(k) Number K143531
Device Name Rapid Therapy System
Applicant
Magstim Company Limited
Spring Gardens, Whitland
Carmarthenshire,  GB SA34 OHR
Applicant Contact Charles Hounsell
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact Steven B Datlof
Regulation Number882.5805
Classification Product Code
OBP  
Date Received12/12/2014
Decision Date 05/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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