Device Classification Name |
micromanipulators and microinjectors, assisted reproduction
|
510(k) Number |
K142207 |
Device Name |
TransferMan 4m Micromanipulator |
Applicant |
EPPENDORF AG |
BARKHANSENWEG 1 |
HAMBURG,
DE
22339
|
|
Applicant Contact |
CORNELIA HILDEBRANDT |
Correspondent |
APTIV SOLUTIONS |
62 Forest Street |
Suite 300 |
Marlborough,
MA
01752
|
|
Correspondent Contact |
JO ANNE BRONIKOWSKI |
Regulation Number | 884.6150
|
Classification Product Code |
|
Date Received | 08/11/2014 |
Decision Date | 01/23/2015 |
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
|
|
|