510(k) K160753

COOK Vacuum Pump by William A. Cook Australia Pty. , Ltd. — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2017
Date Received
March 18, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
Review Panel
OB
Submission Type