ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE

Device, Anti-snoring

FRANTZ DESIGN, INC.

The following data is part of a premarket notification filed by Frantz Design, Inc. with the FDA for Elastic Mandibular Advancement - Titration (ema-t) Appilance.

Pre-market Notification Details

Device IDK973884
510k NumberK973884
Device Name:ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE
ClassificationDevice, Anti-snoring
Applicant FRANTZ DESIGN, INC. 400 MEDICAL CENTER, #209 Webster,  TX  77598
ContactDonald Frantz
CorrespondentDonald Frantz
FRANTZ DESIGN, INC. 400 MEDICAL CENTER, #209 Webster,  TX  77598
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-14
Decision Date1998-01-09
Summary:summary

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