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510(k) K160770

Vent-Os Sinus Dilation family by Sinusys Corporation — Product Code LRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2016
Date Received
March 21, 2016
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

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