FIRST IMPRESSION WITH CHLORHEXIDINE

Material, Impression

COE LABORATORIES, INC.

The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for First Impression With Chlorhexidine.

Pre-market Notification Details

Device IDK894281
510k NumberK894281
Device Name:FIRST IMPRESSION WITH CHLORHEXIDINE
ClassificationMaterial, Impression
Applicant COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip,  IL  60658
ContactRichard Demke
CorrespondentRichard Demke
COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip,  IL  60658
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-23
Decision Date1989-09-26

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