Device Classification Name |
accessory, assisted reproduction
|
510(k) Number |
K160753 |
Device Name |
COOK Vacuum Pump |
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 QLD 4113,
AU
|
|
Correspondent Contact |
Gordana Pozvek |
Regulation Number | 884.6120
|
Classification Product Code |
|
Date Received | 03/18/2016 |
Decision Date | 06/13/2017 |
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
|
Recalls |
CDRH Recalls
|
|
|