OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02

Toothbrush, Powered

OMRON MARSHALL PRODUCTS, INC.

The following data is part of a premarket notification filed by Omron Marshall Products, Inc. with the FDA for Omron Travel Toothbrush, Model Ht-b02.

Pre-market Notification Details

Device IDK901963
510k NumberK901963
Device Name:OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02
ClassificationToothbrush, Powered
Applicant OMRON MARSHALL PRODUCTS, INC. 600 BARCLAY BLVD. Lincolnshire,  IL  60069
ContactCasey Guzniczak
CorrespondentCasey Guzniczak
OMRON MARSHALL PRODUCTS, INC. 600 BARCLAY BLVD. Lincolnshire,  IL  60069
Product CodeJEQ  
CFR Regulation Number872.6865 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-01
Decision Date1990-06-26

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