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510(k) K070865

EXPANDING VASCULAR SHEATH by Applied Medical — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2007
Date Received
March 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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