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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 K993358
Device Name SIGHTSURE OPERATION INDICATOR, MODEL SS301
Applicant
MEDEVICES, INC.
PO BOX 848
GRAYSLAKE,  IL  60030
Applicant Contact MICHELE H VOVOLKA
Correspondent
MEDEVICES, INC.
PO BOX 848
GRAYSLAKE,  IL  60030
Correspondent Contact MICHELE H VOVOLKA
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/06/1999
Decision Date 03/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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