Device Classification Name |
needle, assisted reproduction
|
510(k) Number |
K032208 |
Device Name |
MONA LISA ASPIRATION NEEDLE |
Applicant |
FERTILITY TECHNOLOGY RESOURCES, INC. |
4343 SHALLOWFORD RD. |
SUITE D-4 |
MARIETTA,
GA
30062
|
|
Applicant Contact |
CONSTANCE W STURGEON |
Correspondent |
FERTILITY TECHNOLOGY RESOURCES, INC. |
4343 SHALLOWFORD RD. |
SUITE D-4 |
MARIETTA,
GA
30062
|
|
Correspondent Contact |
CONSTANCE W STURGEON |
Regulation Number | 884.6100
|
Classification Product Code |
|
Date Received | 07/18/2003 |
Decision Date | 12/09/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|