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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K900380
Device Name MEDILASE 5010 ENDOSCOPE CONSOLE
Applicant
MEDICAL LASER, INC.
2605 FERNBROOK LN.
MINNEAPOLIS,  MN  55447
Applicant Contact SHARON KARR
Correspondent
MEDICAL LASER, INC.
2605 FERNBROOK LN.
MINNEAPOLIS,  MN  55447
Correspondent Contact SHARON KARR
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Code
GCT  
Date Received01/26/1990
Decision Date 05/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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