TYMPANOSTOMY TUBE

Tube, Tympanostomy

ACCLARENT, INC.

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

Pre-market Notification Details

Device IDK082188
510k NumberK082188
Device Name:TYMPANOSTOMY TUBE
ClassificationTube, Tympanostomy
Applicant ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park,  CA  94025
ContactKeri Yen
CorrespondentKeri Yen
ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park,  CA  94025
Product CodeETD  
CFR Regulation Number874.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-04
Decision Date2008-09-19
Summary:summary

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