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510(k) K110739

ENTELLUS MEDICAL SINUS GUIDEWIRE by Entellus Medical, Inc. — Product Code LRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2011
Date Received
March 17, 2011
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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  • K130503 — PATHASSIST LED LIGHT FIBER (June 11, 2013)

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  • K172737 — MESIRE - Balloon Sinus Dilatation System (December 12, 2017)
  • K171687 — Relieva SpinPlus Nav Balloon Sinuplasty System (September 5, 2017)