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FDA 510(k) Application Details - K093007
Device Classification Name
Instrument, Ent Manual Surgical
More FDA Info for this Device
510(K) Number
K093007
Device Name
Instrument, Ent Manual Surgical
Applicant
Entellus Medical, Inc.
18555 37TH AVENUE NORTH
PLYMOUTH, MN 55446 US
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Contact
Sew-Wah Tay
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
09/28/2009
Decision Date
02/05/2010
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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