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510(k) K090114

MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S by Oscor, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2009
Date Received
January 21, 2009
Clearance Type
Special
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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