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510(k) K014195

KAYAK HYDROPHILIC GUIDE WIRES by Boston Scientific Corp — Product Code DOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2002
Date Received
December 21, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer, Lead (Dedicated Instruments)
Device Class
Class II
Regulation Number
862.3550
Review Panel
TX
Submission Type

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Other clearances for product code DOX

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