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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 K041021
Device Name RF INTRODUCTION CANNULA
Applicant
EPIMED INTERNATIONAL, INC.
141 SAL LANDRIO DR.
CROSSROADS BUSINESS PARK
JOHNSTOWN,  NY  12095
Applicant Contact CHRISTOPHER B LAKE
Correspondent
EPIMED INTERNATIONAL, INC.
141 SAL LANDRIO DR.
CROSSROADS BUSINESS PARK
JOHNSTOWN,  NY  12095
Correspondent Contact CHRISTOPHER B LAKE
Regulation Number882.4725
Classification Product Code
GXI  
Subsequent Product Code
GXD  
Date Received04/20/2004
Decision Date 09/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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