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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
510(k) Number K900086
Device Name HEMORRHOIDAL LIGATOR WITH SUCTION
Applicant
BAXTER HEALTHCARE CORP.
7280 NORTH CALDWELL
NILES,  IL  60648
Applicant Contact LAJUAN MCGILL
Correspondent
BAXTER HEALTHCARE CORP.
7280 NORTH CALDWELL
NILES,  IL  60648
Correspondent Contact LAJUAN MCGILL
Regulation Number876.5980
Classification Product Code
KDH  
Date Received01/04/1990
Decision Date 03/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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