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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 ROAD
BUILDING 1, SUITE 140
AUSTIN,  TX  78733
Applicant Contact HEATHER CRAWFORD
Correspondent
POST OAK INNOVATIONS, INC.
9433 BEE CAVES ROAD
BUILDING 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
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