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510(k) K050094

LADY COMP USA by Lady Comp USA — Product Code LHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2006
Date Received
January 14, 2005
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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