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510(k) K133990

IEVA REHABILITATIVE POSITIONAL DEVICE by Remendium Labs, LLC — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2014
Date Received
December 27, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perineometer
Device Class
Class II
Regulation Number
884.1425
Review Panel
GU
Submission Type

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