510(k) K181902

Codman Certas Plus Electronic Tool Kit by Integra Lifesciences Corp. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2018
Date Received
July 16, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type