SYNTHES QUICK LOCK IMF SYSTEM

Lock, Wire, And Ligature, Intraoral

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Quick Lock Imf System.

Pre-market Notification Details

Device IDK991004
510k NumberK991004
Device Name:SYNTHES QUICK LOCK IMF SYSTEM
ClassificationLock, Wire, And Ligature, Intraoral
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeDYX  
CFR Regulation Number872.4600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-25
Decision Date1999-06-23
Summary:summary

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