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510(k) K981909

BAXTER HEMOSTASIS VALVE INTRODUCERS by Baxter Edwards — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1998
Date Received
June 1, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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