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510(k) K171193

Certa Catheter by Ferrosan Medical Devices Sp. Z.O.O. — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2017
Date Received
April 24, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type

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