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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fertility Diagnostic, Proceptive
510(k) Number K870999
Device Name GENDER CHOICE INFORMATION KIT, FEMALE AND MALE
Applicant
Procare C/O Wiley, Rein & Fielding
1776 K St. NW
Washington,  DC  20006
Applicant Contact ANDREW S KRULWICH
Correspondent
Procare C/O Wiley, Rein & Fielding
1776 K St. NW
Washington,  DC  20006
Correspondent Contact ANDREW S KRULWICH
Classification Product Code
LHD  
Date Received03/11/1987
Decision Date 07/14/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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