Device Classification Name |
Device, Fertility Diagnostic, Proceptive
|
510(k) Number |
K002726 |
Device Name |
TCOYF FERTILITY SOFTWARE VERSION 1.0 |
Applicant |
OVUSOFT, LLC. |
402 DUNHAM MASSIE DR. |
HAMPTON,
VA
23669 -1744
|
|
Applicant Contact |
GENE GRANT |
Correspondent |
OVUSOFT, LLC. |
402 DUNHAM MASSIE DR. |
HAMPTON,
VA
23669 -1744
|
|
Correspondent Contact |
GENE GRANT |
Classification Product Code |
|
Date Received | 08/31/2000 |
Decision Date | 04/06/2001 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|