Encore System

Prelude Tongue Suspension System

Siesta Medical, Inc.

The following data is part of a premarket notification filed by Siesta Medical, Inc. with the FDA for Encore System.

Pre-market Notification Details

Device IDK201238
510k NumberK201238
Device Name:Encore System
ClassificationPrelude Tongue Suspension System
Applicant Siesta Medical, Inc. 101 Church Street, Suite 3 Los Gatos,  CA  95030
ContactMichael Kolber
CorrespondentMichael Kolber
Siesta Medical, Inc. 101 Church Street, Suite 3 Los Gatos,  CA  95030
Product CodeORY  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-07
Decision Date2020-10-02

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