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510(k) K092401

SINEXUS SINUS STENT GEN 2, MODEL 1999-25 by Sinexus, Inc. — Product Code LYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2009
Date Received
August 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Intranasal Septal
Device Class
Class I
Regulation Number
874.4780
Review Panel
EN
Submission Type

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