510(k) K172050

Follicle Aspiration Set, Reduced Single Lumen by Vitrolife Sweden AB — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2017
Date Received
July 6, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6100
Review Panel
OB
Submission Type