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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K915458
Device Name URETEROSCOPE
Applicant
PSI MEDICAL PRODUCTS, INC.
495 WESTPORT AVE.
NORWALK,  CT  06851
Applicant Contact JOHN J SOKOLOWSKI
Correspondent
PSI MEDICAL PRODUCTS, INC.
495 WESTPORT AVE.
NORWALK,  CT  06851
Correspondent Contact JOHN J SOKOLOWSKI
Regulation Number876.1500
Classification Product Code
FGB  
Date Received12/04/1991
Decision Date 01/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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