510(k) K232677

Reia pessary by Reia, LLC — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2024
Date Received
September 1, 2023
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