FIRST IMPRESSION TM

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 Tm.

Pre-market Notification Details

Device IDK894282
510k NumberK894282
Device Name:FIRST IMPRESSION TM
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 Date1989-12-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D6581216301 K894282 000
10386040004695 K894282 000
10386040004701 K894282 000
20386040004715 K894282 000
20386040004722 K894282 000
20386040004746 K894282 000
20386040004777 K894282 000
20386040004784 K894282 000
10386040004794 K894282 000
20386040004685 K894282 000

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