PALAVIT GLC

Wax, Dental, Intraoral

KULZER, INC.

The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Palavit Glc.

Pre-market Notification Details

Device IDK904928
510k NumberK904928
Device Name:PALAVIT GLC
ClassificationWax, Dental, Intraoral
Applicant KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine,  CA  92718
ContactSharon Parker
CorrespondentSharon Parker
KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine,  CA  92718
Product CodeEGD  
CFR Regulation Number872.6890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-31
Decision Date1991-06-06

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