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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Flexible Suction Coagulator
510(k) Number K130489
Device Name ELECTRODE, FLEXIBLE SUCTION COAGULATOR
Applicant
OPTIM, LLC.
64 TECHNOLOGY PARK RD.
STURBRIDGE,  MA  01566
Applicant Contact JEFF BARRETT, CEO
Correspondent
OPTIM, LLC.
64 TECHNOLOGY PARK RD.
STURBRIDGE,  MA  01566
Correspondent Contact JEFF BARRETT, CEO
Regulation Number876.4300
Classification Product Code
FEH  
Date Received02/25/2013
Decision Date 04/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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