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510(k) K111763

PATHASSIST LIGHT FIBER by Entellus Medical, Inc. — Product Code LRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2011
Date Received
June 23, 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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  • K141916 — PATHASSIST LED LIGHT FIBER (August 7, 2014)
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  • K132440 — XPRESS MULTI-SINUS DILATION TOOL (October 4, 2013)
  • K130503 — PATHASSIST LED LIGHT FIBER (June 11, 2013)

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