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510(k) K002534

EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 by Eupalamus, LLC — Product Code DRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2000
Date Received
August 16, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Catheter
Device Class
Class II
Regulation Number
870.1380
Review Panel
CV
Submission Type

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