PILLAR PALATAL IMPLANT SYSTEM

Device, Anti-snoring

RESTORE MEDICAL INC.

The following data is part of a premarket notification filed by Restore Medical Inc. with the FDA for Pillar Palatal Implant System.

Pre-market Notification Details

Device IDK040417
510k NumberK040417
Device Name:PILLAR PALATAL IMPLANT SYSTEM
ClassificationDevice, Anti-snoring
Applicant RESTORE MEDICAL INC. 2800 PATTON RD. St Paul,  MN  55113
ContactEdward W Numainville
CorrespondentEdward W Numainville
RESTORE MEDICAL INC. 2800 PATTON RD. St Paul,  MN  55113
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-18
Decision Date2004-07-28
Summary:summary

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