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510(k) K083451

PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS by Smiths Medical Asd, Inc. — Product Code BSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2009
Date Received
November 21, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5130
Review Panel
AN
Submission Type

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