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510(k) K090163

STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 by St Jude Medical — Product Code DRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2009
Date Received
January 22, 2009
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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