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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image, Illumination, Fiberoptic, For Endoscope
510(k) Number K072521
Device Name COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
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
FFS  
Subsequent Product Codes
FAJ   FED   FGA   FGB   GCJ  
Date Received09/07/2007
Decision Date 11/20/2007
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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