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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Endometrial
510(k) Number K082066
Device Name TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
Applicant
Cook Urological, Inc.
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact CINDY FOOTE
Correspondent
Cook Urological, Inc.
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact CINDY FOOTE
Regulation Number884.1100
Classification Product Code
HFE  
Date Received07/22/2008
Decision Date 11/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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