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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 K090608
Device Name MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
Applicant
Minta Medical Limited
Caddick Rd.
Knowsley Merseyside,  GB L34 9HP
Applicant Contact ANDREW EDWARDS
Correspondent
Minta Medical Limited
Caddick Rd.
Knowsley Merseyside,  GB L34 9HP
Correspondent Contact ANDREW EDWARDS
Regulation Number882.4725
Classification Product Code
GXI  
Date Received03/06/2009
Decision Date 06/14/2010
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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