THE HERBST APPLIANCE

Bracket, Metal, Orthodontic

ORMCO CORP.

The following data is part of a premarket notification filed by Ormco Corp. with the FDA for The Herbst Appliance.

Pre-market Notification Details

Device IDK923405
510k NumberK923405
Device Name:THE HERBST APPLIANCE
ClassificationBracket, Metal, Orthodontic
Applicant ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora,  CA  91740
ContactFrances Zee
CorrespondentFrances Zee
ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora,  CA  91740
Product CodeEJF  
CFR Regulation Number872.5410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-10
Decision Date1993-05-05

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