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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 K170603
Device Name Tao Brush I.U.M.C. Endometrial Sampler
Applicant
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Applicant Contact Ian Herman
Correspondent
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact Ian Herman
Regulation Number884.1100
Classification Product Code
HFE  
Date Received03/01/2017
Decision Date 05/24/2017
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
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