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FDA 510(k) Application Details - K121174
Device Classification Name
Instrument, Ent Manual Surgical
More FDA Info for this Device
510(K) Number
K121174
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
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Classification Product Code
LRC
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More FDA Info for this Product Code
Date Received
04/17/2012
Decision Date
05/17/2012
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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