510(k) K082066

TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER by Cook Urological, Inc. — Product Code HFE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2008
Date Received
July 22, 2008
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