Device Classification Name |
needle, assisted reproduction
|
510(k) Number |
K013497 |
Device Name |
FAS SET #4551 |
Applicant |
GYNETICS MEDICAL PRODUCTS NV |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
GRACE HOLLAND |
Correspondent |
GYNETICS MEDICAL PRODUCTS NV |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
GRACE HOLLAND |
Regulation Number | 884.6100
|
Classification Product Code |
|
Date Received | 10/22/2001 |
Decision Date | 11/09/2001 |
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
|
|
|