510(k) K132313

PESSARY by Eis Corporation — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2014
Date Received
July 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pessary, Vaginal
Device Class
Class II
Regulation Number
884.3575
Review Panel
OB
Submission Type