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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ligator, Esophageal
510(k) Number K031236
Device Name AUTO-BAND LIGATOR
Applicant
SCANDIMED. A.S.
SLOTSHERRENSVEJ 409
GLOSTROP,  DK DK 2600
Applicant Contact KRISTIAN K JENSEN
Correspondent
SCANDIMED. A.S.
SLOTSHERRENSVEJ 409
GLOSTROP,  DK DK 2600
Correspondent Contact KRISTIAN K JENSEN
Regulation Number876.4400
Classification Product Code
MND  
Date Received04/18/2003
Decision Date 11/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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