VF LIQUIGEL

System, Vocal Cord Medialization

COAPT SYSTEMS, INC.

The following data is part of a premarket notification filed by Coapt Systems, Inc. with the FDA for Vf Liquigel.

Pre-market Notification Details

Device IDK083783
510k NumberK083783
Device Name:VF LIQUIGEL
ClassificationSystem, Vocal Cord Medialization
Applicant COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto,  CA  94303
ContactLouis-pierre Marcoux
CorrespondentLouis-pierre Marcoux
COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto,  CA  94303
Product CodeMIX  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-19
Decision Date2009-09-11
Summary:summary

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