STAINLESS STEEL ARCHES

Wire, Orthodontic

HIGHLAND METALS

The following data is part of a premarket notification filed by Highland Metals with the FDA for Stainless Steel Arches.

Pre-market Notification Details

Device IDK933379
510k NumberK933379
Device Name:STAINLESS STEEL ARCHES
ClassificationWire, Orthodontic
Applicant HIGHLAND METALS P.O. BOX 23216 San Jose,  CA  95153
ContactKenneth Highland
CorrespondentKenneth Highland
HIGHLAND METALS P.O. BOX 23216 San Jose,  CA  95153
Product CodeDZC  
CFR Regulation Number872.5410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-09
Decision Date1993-11-12

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