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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic access overtube, gastroenterology-urology
510(k) Number K912265
Device Name MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000
Applicant
MEDICAL LASER, INC.
2605 FERNBROOK LN.
MINNEAPOLIS,  MN  55447
Applicant Contact GREGORY J MATHISON
Correspondent
MEDICAL LASER, INC.
2605 FERNBROOK LN.
MINNEAPOLIS,  MN  55447
Correspondent Contact GREGORY J MATHISON
Regulation Number876.1500
Classification Product Code
FED  
Date Received05/22/1991
Decision Date 10/10/1991
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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