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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic injection needle, gastroenterology-urology
510(k) Number K022484
Device Name COOK INJECTION NEEDLE
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact DEBBIE SCHMITT
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact DEBBIE SCHMITT
Regulation Number876.1500
Classification Product Code
FBK  
Date Received07/29/2002
Decision Date 10/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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