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FDA 510(k) Application Details - K113522
Device Classification Name
Instrument, Ent Manual Surgical
More FDA Info for this Device
510(K) Number
K113522
Device Name
Instrument, Ent Manual Surgical
Applicant
Entellus Medical, Inc.
6705 WEDGWOOD COURT NORTH
MAPLE GROVE, MN 55311 US
Other 510(k) Applications for this Company
Contact
GARRETT P AHLBORG
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
11/29/2011
Decision Date
01/27/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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