GLENROE PLASTIC BRACKET

Bracket, Plastic, Orthodontic

GLENROE TECHNOLOGIES

The following data is part of a premarket notification filed by Glenroe Technologies with the FDA for Glenroe Plastic Bracket.

Pre-market Notification Details

Device IDK932920
510k NumberK932920
Device Name:GLENROE PLASTIC BRACKET
ClassificationBracket, Plastic, Orthodontic
Applicant GLENROE TECHNOLOGIES 1912 44TH AVE., EAST Bradenton,  FL  34203
ContactJohn F Bozman
CorrespondentJohn F Bozman
GLENROE TECHNOLOGIES 1912 44TH AVE., EAST Bradenton,  FL  34203
Product CodeDYW  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-15
Decision Date1993-08-24

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