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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nephrostomy
510(k) Number K011121
Device Name RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
Applicant
Rusch Intl.
50 Plantation Dr.
Jaffrey,  NH  03452
Applicant Contact JULIE A BEAUMONT
Correspondent
Rusch Intl.
50 Plantation Dr.
Jaffrey,  NH  03452
Correspondent Contact JULIE A BEAUMONT
Classification Product Code
LJE  
Date Received04/12/2001
Decision Date 11/16/2001
Decision Substantially Equivalent (SESE)
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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