COE PAK AUTO MIX, REGULAR OR HARD SET

Cement, Dental

COE LABORATORIES, INC.

The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for Coe Pak Auto Mix, Regular Or Hard Set.

Pre-market Notification Details

Device IDK881422
510k NumberK881422
Device Name:COE PAK AUTO MIX, REGULAR OR HARD SET
ClassificationCement, Dental
Applicant COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip,  IL  60658
ContactBrahma D Sharma,phd
CorrespondentBrahma D Sharma,phd
COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip,  IL  60658
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-05
Decision Date1988-10-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10386040000321 K881422 000
20386040000311 K881422 000
20386040000304 K881422 000

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