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510(k) K122337

OVUSENSE by Fertility Focus, Ltd. — Product Code LHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2013
Date Received
August 2, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fertility Diagnostic, Proceptive
Device Class
Class U
Regulation Number
Review Panel
OB
Submission Type

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