LEE-ALLOY

Alloy, Amalgam

LEE PHARMACEUTICALS

The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Lee-alloy.

Pre-market Notification Details

Device IDK780967
510k NumberK780967
Device Name:LEE-ALLOY
ClassificationAlloy, Amalgam
Applicant LEE PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEJJ  
CFR Regulation Number872.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-06-12
Decision Date1978-06-22

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