510(k) K131198

TIPI OTC by Contipi , Ltd. — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2013
Date Received
April 26, 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