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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 K082319
Device Name INJEKT FILIFORM INJECTION NEEDLE
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
SPENCER,  IN  47460
Applicant Contact CINDY FOOTE
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
SPENCER,  IN  47460
Correspondent Contact CINDY FOOTE
Regulation Number876.1500
Classification Product Code
FBK  
Date Received08/13/2008
Decision Date 09/25/2008
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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