510(k) K201213

Pasteur Pipette 3mL, Pasteur Pipette 1mL by Hertart Aps — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2020
Date Received
May 5, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type