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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 K081142
Device Name AUTO-BAND LIGATOR
Applicant
Scandimed International
409 Slotsherrensvej
Glostrop,  DK DK 2600
Applicant Contact SALAH CHAMI
Correspondent
Scandimed International
409 Slotsherrensvej
Glostrop,  DK DK 2600
Correspondent Contact SALAH CHAMI
Regulation Number876.4400
Classification Product Code
MND  
Date Received04/22/2008
Decision Date 05/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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