Device Classification Name |
Labware, Assisted Reproduction
|
510(k) Number |
K201213 |
Device Name |
Pasteur Pipette 3mL, Pasteur Pipette 1mL |
Applicant |
HertART Aps |
Gustaf Werners gata 2 |
Vastra Frolunda,
SE
SE-421 32
|
|
Applicant Contact |
Per Svensson |
Correspondent |
HertART Aps |
Gustaf Werners gata 2 |
Vastra Frolunda,
SE
SE-421 32
|
|
Correspondent Contact |
Ann-Catherine Ericson |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 05/05/2020 |
Decision Date | 12/16/2020 |
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
|
|
|