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FDA 510(k) Application Details - K200952
Device Classification Name
Tube, Tympanostomy
More FDA Info for this Device
510(K) Number
K200952
Device Name
Tube, Tympanostomy
Applicant
Preceptis Medical, Inc
10900 89th Ave N
Suite 4
Maple Grove, MN 55369 US
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Contact
Steve Anderson
Other 510(k) Applications for this Contact
Regulation Number
874.3880
More FDA Info for this Regulation Number
Classification Product Code
ETD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/09/2020
Decision Date
06/05/2020
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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