TULA IONTOPHORESIS SYSTEM

Device, Iontophoresis, Other Uses

ACCLARENT, INC.

The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Tula Iontophoresis System.

Pre-market Notification Details

Device IDK110636
510k NumberK110636
Device Name:TULA IONTOPHORESIS SYSTEM
ClassificationDevice, Iontophoresis, Other Uses
Applicant ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park,  CA  94025
ContactGurvinder Singh Nanda
CorrespondentGurvinder Singh Nanda
ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park,  CA  94025
Product CodeEGJ  
CFR Regulation Number890.5525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-04
Decision Date2011-06-16
Summary:summary

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