Device Classification Name |
accessory, assisted reproduction
|
510(k) Number |
K020560 |
Device Name |
WORKBENCH BY |
Applicant |
GENX INTL., INC. |
393 SOUNDVIEW RD. |
GUILFORD,
CT
06437
|
|
Applicant Contact |
MICHAEL D CECCHI |
Correspondent |
GENX INTL., INC. |
393 SOUNDVIEW RD. |
GUILFORD,
CT
06437
|
|
Correspondent Contact |
MICHAEL D CECCHI |
Regulation Number | 884.6120
|
Classification Product Code |
|
Date Received | 02/20/2002 |
Decision Date | 06/19/2002 |
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
|
|
|