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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 K911324
Device Name IRRIGATION/ASPIRATION TUBING SET
Applicant
Biomedical Dynamics, Inc.
12250 Nicollet Ave.
Burnsville,  MN  55337
Applicant Contact MATTHEW E BELLIN
Correspondent
Biomedical Dynamics, Inc.
12250 Nicollet Ave.
Burnsville,  MN  55337
Correspondent Contact MATTHEW E BELLIN
Regulation Number876.5980
Classification Product Code
KDH  
Date Received03/26/1991
Decision Date 06/24/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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