510(k) K093508

RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) by Womancare Global — Product Code HGH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2010
Date Received
November 12, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Suction, Uterine
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type