MIRROR, MOUTH

Burnisher, Operative

PROTECTOR, INC.

The following data is part of a premarket notification filed by Protector, Inc. with the FDA for Mirror, Mouth.

Pre-market Notification Details

Device IDK925890
510k NumberK925890
Device Name:MIRROR, MOUTH
ClassificationBurnisher, Operative
Applicant PROTECTOR, INC. C/O ASIAN PACIFIC IMPORTS P.O. BOX 92195 Long Beach,  CA  90809
ContactMichael W Guenther
CorrespondentMichael W Guenther
PROTECTOR, INC. C/O ASIAN PACIFIC IMPORTS P.O. BOX 92195 Long Beach,  CA  90809
Product CodeEKJ  
CFR Regulation Number872.4565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-16
Decision Date1994-02-15

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