ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN

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 Tongue Suspension System (monofilament #1 Suspension Suture), Encore Tongue Suspension System System (monofilamen.

Pre-market Notification Details

Device IDK111179
510k NumberK111179
Device Name:ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN
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 Received2011-04-27
Decision Date2011-07-01
Summary:summary

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