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510(k) K183468

Revive Reusable Bladder Support by Rinovum Subsidiary 2, LLC — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2019
Date Received
December 14, 2018
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

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