RELIENT NAVIGATION DEVICE

Cannula, Sinus

ACCLARENT, INC.

The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relient Navigation Device.

Pre-market Notification Details

Device IDK060974
510k NumberK060974
Device Name:RELIENT NAVIGATION DEVICE
ClassificationCannula, Sinus
Applicant ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park,  CA  94025
ContactSu-mien Chong
CorrespondentSu-mien Chong
ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park,  CA  94025
Product CodeKAM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-10
Decision Date2006-05-05
Summary:summary

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