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FDA 510(k) Application Details - K181546
Device Classification Name
Instrument, Ent Manual Surgical
More FDA Info for this Device
510(K) Number
K181546
Device Name
Instrument, Ent Manual Surgical
Applicant
Intuit Medical Products, LLC
6018 Eagles Rest Trail
Sugar Hill, GA 30518 US
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Contact
Jack Griffis
Other 510(k) Applications for this Contact
Regulation Number
874.4420
More FDA Info for this Regulation Number
Classification Product Code
LRC
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More FDA Info for this Product Code
Date Received
06/12/2018
Decision Date
01/03/2020
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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