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510(k) K163031

Bunegin-Albin Air Aspiration Set by Cook Incorporated — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2017
Date Received
October 31, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

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