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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K072550
Device Name SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301
Applicant
MEDEVICE, INC.
P.O. BOX 848
GRAYSLAKE,  IL  60030
Applicant Contact MICHELE H VOVOLKA
Correspondent
MEDEVICE, INC.
P.O. BOX 848
GRAYSLAKE,  IL  60030
Correspondent Contact MICHELE H VOVOLKA
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/10/2007
Decision Date 12/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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