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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, ent manual surgical
510(k) Number K111763
FOIA Releasable 510(k) K111763
Device Name PATHASSIST LIGHT FIBER
Applicant
Entellus Medical, Inc.
6705 WEDGWOOD COURT NORTH
MAPLE GROVE,  MN  55311
Applicant Contact KAREN E PETERSON
Correspondent
Entellus Medical, Inc.
6705 WEDGWOOD COURT NORTH
MAPLE GROVE,  MN  55311
Correspondent Contact KAREN E PETERSON
Regulation Number874.4420
Classification Product Code
LRC  
Date Received06/23/2011
Decision Date 09/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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