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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K971764
Device Name WELCON HUE-VU URINARY DRAINAGE BAG
Applicant
Welcon, Inc.
99 Hartford Ave.
Providence,  RI  02909
Applicant Contact GEORGE HIRD
Correspondent
Welcon, Inc.
99 Hartford Ave.
Providence,  RI  02909
Correspondent Contact GEORGE HIRD
Regulation Number876.5250
Classification Product Code
KNX  
Date Received05/13/1997
Decision Date 07/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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