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FDA 510(k) Application Details - K203754
Device Classification Name
Device, Inflation, Middle Ear
More FDA Info for this Device
510(K) Number
K203754
Device Name
Device, Inflation, Middle Ear
Applicant
Exercore, LLC
8170 Old Carriage Court N, Suite 200
Shakopee, MN 55379 US
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Contact
Kevin Connelly
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MJV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/23/2020
Decision Date
02/19/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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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