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 STREET, N.W. |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
ANDREW S KRULWICH |
Correspondent |
PROCARE C/O WILEY, REIN & FIELDING |
1776 K STREET, N.W. |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
ANDREW S KRULWICH |
Classification Product Code |
|
Date Received | 03/11/1987 |
Decision Date | 07/14/1987 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|