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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 K915209
Device Name MALECOT-NEPHROSTOMY TAMPONADE CATHETER
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact MICHELLE YOUNG
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact MICHELLE YOUNG
Classification Product Code
LJE  
Date Received11/18/1991
Decision Date 11/10/1992
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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