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510(k) K133016

VENT-OS SINUS DILATION SYSTEM by Sinusys Corporation — Product Code LRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2013
Date Received
September 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ent Manual Surgical
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Sinusys Corporation

  • K160770 — Vent-Os Sinus Dilation family (June 29, 2016)

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