Device Classification Name |
labware, assisted reproduction
|
510(k) Number |
K140207 |
Device Name |
RAPID-I KIT |
Applicant |
VITROLIFE SWEDEN AB |
1111 PENNSYLVANIA AVENUE,NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
ANTHONY T PAVEL |
Correspondent |
VITROLIFE SWEDEN AB |
1111 PENNSYLVANIA AVENUE,NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
ANTHONY T PAVEL |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 01/28/2014 |
Decision Date | 12/18/2014 |
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
|
|
|