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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
510(k) Number K904158
Device Name ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY
Applicant
Welcon, Inc.
99 Hartford Ave.
Providence,  RI  02909
Applicant Contact RICHARD P WELCH
Correspondent
Welcon, Inc.
99 Hartford Ave.
Providence,  RI  02909
Correspondent Contact RICHARD P WELCH
Regulation Number876.5130
Classification Product Code
FCM  
Date Received09/07/1990
Decision Date 11/29/1990
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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