MODIFICATION TO VF GEL PLUS

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 Modification To Vf Gel Plus.

Pre-market Notification Details

Device IDK080956
510k NumberK080956
Device Name:MODIFICATION TO VF GEL PLUS
ClassificationSystem, Vocal Cord Medialization
Applicant COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto,  CA  94303
ContactLinda Ruedy
CorrespondentLinda Ruedy
COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto,  CA  94303
Product CodeMIX  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-03
Decision Date2008-04-25
Summary:summary

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