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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 K112763
Device Name MATRIXBRUSH ENDOMETRIAL SAMPLER
Applicant
Post Oak Innovations, Inc.
9433 Bee Caves Rd.
Bldg. 1 Suite 140
Austin,  TX  78733
Applicant Contact HEATHER CRAWFORD
Correspondent
Post Oak Innovations, Inc.
9433 Bee Caves Rd.
Bldg. 1 Suite 140
Austin,  TX  78733
Correspondent Contact HEATHER CRAWFORD
Regulation Number884.1100
Classification Product Code
HFE  
Date Received09/22/2011
Decision Date 06/18/2012
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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