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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K981405
Device Name SYNERGY LT
Applicant
OXFORD INSTRUMENTS, PLC.
MANOR WAY
OLD WOKING , SURREY,  GB 9022 0JU
Applicant Contact JEFF HALL
Correspondent
OXFORD INSTRUMENTS, PLC.
MANOR WAY
OLD WOKING , SURREY,  GB 9022 0JU
Correspondent Contact JEFF HALL
Regulation Number882.1870
Classification Product Code
GWF  
Date Received04/20/1998
Decision Date 07/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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