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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 K892334
Device Name LEONARD TUBE
Applicant
Surgidyne, Inc.
9605 W. Jefferson Trl.
Inver Grove Heights,  MN  55077
Applicant Contact B MCNEIL
Correspondent
Surgidyne, Inc.
9605 W. Jefferson Trl.
Inver Grove Heights,  MN  55077
Correspondent Contact B MCNEIL
Regulation Number876.5980
Classification Product Code
KDH  
Date Received04/05/1989
Decision Date 05/31/1989
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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