Device Classification Name |
catheter, assisted reproduction
|
510(k) Number |
K992307 |
Device Name |
EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER |
Applicant |
FERTILITY TECHNOLOGY RESOURCES, INC. |
4343 SHALLOWFORD RD. |
SUITE D-4 |
MARIETTA,
GA
30062
|
|
Correspondent |
FERTILITY TECHNOLOGY RESOURCES, INC. |
4343 SHALLOWFORD RD. |
SUITE D-4 |
MARIETTA,
GA
30062
|
|
Regulation Number | 884.6110
|
Classification Product Code |
|
Date Received | 07/09/1999 |
Decision Date | 09/13/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|