Device Classification Name |
labware, assisted reproduction
|
510(k) Number |
K131145 |
Device Name |
PROINSERT |
Applicant |
NIDACON INTERNATIONAL AB |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
NIDACON INTERNATIONAL AB |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 04/23/2013 |
Decision Date | 02/20/2014 |
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
|
|
|