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510(k) K002726

TCOYF FERTILITY SOFTWARE VERSION 1.0 by Ovusoft, LLC — Product Code LHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2001
Date Received
August 31, 2000
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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