Device Classification Name |
media, reproductive
|
510(k) Number |
K151367 |
Device Name |
Sydney IVF Hyaluronidase |
Applicant |
WILLIAM A. COOK AUSTRALIA PTY LTD |
95 BRANDL STREET |
EIGHT MILE PLAINS,
AU
4113
|
|
Applicant Contact |
GORDANA POZVEK |
Correspondent |
WILLIAM A. COOK AUSTRALIA PTY LTD |
95 BRANDL STREET |
EIGHT MILE PLAINS,
AU
4113
|
|
Correspondent Contact |
GORDANA POZVEK |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 05/21/2015 |
Decision Date | 01/27/2016 |
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
|
|
|