LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS

Bracket, Plastic, Orthodontic

LEE PHARMACEUTICALS

The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Lee-fischer Ceramic Reinforced Plastic Brackets.

Pre-market Notification Details

Device IDK900809
510k NumberK900809
Device Name:LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS
ClassificationBracket, Plastic, Orthodontic
Applicant LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte,  CA  91733
ContactLee, Ph.d.
CorrespondentLee, Ph.d.
LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte,  CA  91733
Product CodeDYW  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-21
Decision Date1990-06-28

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