510(k) K870999

GENDER CHOICE INFORMATION KIT, FEMALE AND MALE by Procare C/O Wiley, Rein & Fielding — Product Code LHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1987
Date Received
March 11, 1987
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