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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K921415
Device Name IRRIGATION TUBING SET
Applicant
Psi Medical Products, Inc.
495 Westport Ave.
Norwalk,  CT  06851
Applicant Contact JOHN JSOKOLOWSKI
Correspondent
Psi Medical Products, Inc.
495 Westport Ave.
Norwalk,  CT  06851
Correspondent Contact JOHN JSOKOLOWSKI
Regulation Number876.5130
Classification Product Code
KOD  
Date Received03/24/1992
Decision Date 09/04/1992
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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