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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K994344
Device Name NEUROTHERM RF CANNULA
Applicant
Rocket Medical Plc
Factories 3 & 4,
Wear Industrial Estate
Washington, Tyne & Wear,  GB NE37 1NE
Applicant Contact LES TODD
Correspondent
Rocket Medical Plc
Factories 3 & 4,
Wear Industrial Estate
Washington, Tyne & Wear,  GB NE37 1NE
Correspondent Contact LES TODD
Regulation Number882.4725
Classification Product Code
GXI  
Date Received12/22/1999
Decision Date 03/21/2000
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
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