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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 K122593
Device Name PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
Applicant
OPTIM LLC
64 TECHNOLOGY PARK RD
STURBRIDGE,  MA  01566
Applicant Contact JEFF BARRETT
Correspondent
OPTIM LLC
64 TECHNOLOGY PARK RD
STURBRIDGE,  MA  01566
Correspondent Contact JEFF BARRETT
Regulation Number876.4300
Classification Product Code
FEH  
Date Received08/24/2012
Decision Date 09/13/2012
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
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