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FDA 510(k) Application Details - K110158
Device Classification Name
Instrument, Ent Manual Surgical
More FDA Info for this Device
510(K) Number
K110158
Device Name
Instrument, Ent Manual Surgical
Applicant
Entellus Medical, Inc.
6705 WEDGWOOD COURT NORTH
MAPLE GROVE, MN 55311 US
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Contact
KAREN E PETERSON
Other 510(k) Applications for this Contact
Regulation Number
874.4420
More FDA Info for this Regulation Number
Classification Product Code
LRC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/19/2011
Decision Date
06/07/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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