CFR MONOGRAPH

Cleanser, Denture, Over The Counter

COMBE, INC.

The following data is part of a premarket notification filed by Combe, Inc. with the FDA for Cfr Monograph.

Pre-market Notification Details

Device IDK925259
510k NumberK925259
Device Name:CFR MONOGRAPH
ClassificationCleanser, Denture, Over The Counter
Applicant COMBE, INC. 1101 WESTCHESTER AVE. White Plains,  NY  10604
ContactDaniel R Johnson
CorrespondentDaniel R Johnson
COMBE, INC. 1101 WESTCHESTER AVE. White Plains,  NY  10604
Product CodeEFT  
CFR Regulation Number872.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-19
Decision Date1993-01-11

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