510(k) K070047

NUNC IVF DISHES AND NUNC IVF 4-WELL DISH by Nunc A/S — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2007
Date Received
January 4, 2007
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