Device Classification Name |
device, fertility diagnostic, proceptive
|
510(k) Number |
K021978 |
Device Name |
PETIT SOPHIA |
Applicant |
NISHITOMO CO., INC. |
3696 WEST MAIN ST. |
GRAY,
LA
70359
|
|
Applicant Contact |
LLOYD DUPLANTIS |
Correspondent |
NISHITOMO CO., INC. |
3696 WEST MAIN ST. |
GRAY,
LA
70359
|
|
Correspondent Contact |
LLOYD DUPLANTIS |
Classification Product Code |
|
Date Received | 06/17/2002 |
Decision Date | 04/08/2003 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|