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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 K983624
Device Name GILTECH PLUS CONNECTING TUBE SET
Applicant
Giltech Plus, Inc.
P.O. Box 728
Milford,  PA  18337
Applicant Contact WILLIAM J GILIAM
Correspondent
Giltech Plus, Inc.
P.O. Box 728
Milford,  PA  18337
Correspondent Contact WILLIAM J GILIAM
Regulation Number876.5980
Classification Product Code
KDH  
Date Received10/15/1998
Decision Date 03/18/1999
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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