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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Guidewire, Gastroenterology-Urology
510(k) Number K082536
Device Name COOK WIRE GUIDES
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
Spencer,  IN  47460
Applicant Contact CINDY FOOTE
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
Spencer,  IN  47460
Correspondent Contact CINDY FOOTE
Regulation Number876.1500
Classification Product Code
OCY  
Date Received09/02/2008
Decision Date 10/27/2008
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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