Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K112856 |
Device Name |
LUCINA-MELODI |
Applicant |
GENADYNE BIOTECHNOLOGIES, INC. |
16 MIDLAND AVE |
HICKSVILLE,
NY
11801
|
|
Applicant Contact |
CHIEN-MING GOH |
Correspondent |
GENADYNE BIOTECHNOLOGIES, INC. |
16 MIDLAND AVE |
HICKSVILLE,
NY
11801
|
|
Correspondent Contact |
CHIEN-MING GOH |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 09/30/2011 |
Decision Date | 05/10/2012 |
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
|
|
|