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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Ureteral Catheter
510(k) Number K934419
Device Name URETERAL CATHETER AND ACCESSORIES
Applicant
Urological Associates of Central Jersey P.A.
904 Oak Tree Rd.
Suite J
South Plainfield,  NJ  07080
Applicant Contact ANTHONY SOLAZZO
Correspondent
Urological Associates of Central Jersey P.A.
904 Oak Tree Rd.
Suite J
South Plainfield,  NJ  07080
Correspondent Contact ANTHONY SOLAZZO
Regulation Number876.5130
Classification Product Code
EYK  
Date Received09/13/1993
Decision Date 05/25/1994
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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