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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 K926423
Device Name S/2(TM) STOPCOCK
Applicant
PSI MEDICAL PRODUCTS, INC.
240 LONG HILL CROSS RD.
SHELTON,  CT  06484
Applicant Contact JOHN J SOKOLOWSKI
Correspondent
PSI MEDICAL PRODUCTS, INC.
240 LONG HILL CROSS RD.
SHELTON,  CT  06484
Correspondent Contact JOHN J SOKOLOWSKI
Regulation Number876.1500
Classification Product Code
FGB  
Date Received12/23/1992
Decision Date 03/23/1993
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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