OTC DENTURE CLEANSER

Cleanser, Denture, Over The Counter

COMBE, INC.

The following data is part of a premarket notification filed by Combe, Inc. with the FDA for Otc Denture Cleanser.

Pre-market Notification Details

Device IDK942203
510k NumberK942203
Device Name:OTC DENTURE CLEANSER
ClassificationCleanser, Denture, Over The Counter
Applicant COMBE, INC. 1101 WESTCHESTER AVE. White Plains,  NY  10604
ContactStephen C Pennisi
CorrespondentStephen C Pennisi
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 Received1994-05-05
Decision Date1994-08-10

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