Hummingbird Tympanostomy Tube System

Tube, Tympanostomy

Preceptis Medical, Inc

The following data is part of a premarket notification filed by Preceptis Medical, Inc with the FDA for Hummingbird Tympanostomy Tube System.

Pre-market Notification Details

Device IDK200952
510k NumberK200952
Device Name:Hummingbird Tympanostomy Tube System
ClassificationTube, Tympanostomy
Applicant Preceptis Medical, Inc 10900 89th Ave N Suite 4 Maple Grove,  MN  55369
ContactSteve Anderson
CorrespondentSteve Anderson
Preceptis Medical, Inc 10900 89th Ave N Suite 4 Maple Grove,  MN  55369
Product CodeETD  
CFR Regulation Number874.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-09
Decision Date2020-06-05

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