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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 K923303
Device Name SAPPHIRE PREMIERE
Applicant
Medelec , Ltd.
Manor Way
Old Woking
Surrey, England Gu22 9ju,  GB
Applicant Contact HOLLOWAY
Correspondent
Medelec , Ltd.
Manor Way
Old Woking
Surrey, England Gu22 9ju,  GB
Correspondent Contact HOLLOWAY
Regulation Number882.1870
Classification Product Code
GWF  
Date Received07/06/1992
Decision Date 11/24/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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