510(k) K112763

MATRIXBRUSH ENDOMETRIAL SAMPLER by Post Oak Innovations, Inc. — Product Code HFE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2012
Date Received
September 22, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Endometrial
Device Class
Class II
Regulation Number
884.1100
Review Panel
OB
Submission Type