PARKELL RESIN GLAZE

Coating, Filling Material, Resin

PARKELL, INC.

The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Parkell Resin Glaze.

Pre-market Notification Details

Device IDK040599
510k NumberK040599
Device Name:PARKELL RESIN GLAZE
ClassificationCoating, Filling Material, Resin
Applicant PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale,  NY  11735
ContactNelson J Gendusa
CorrespondentNelson J Gendusa
PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale,  NY  11735
Product CodeEBD  
CFR Regulation Number872.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-08
Decision Date2004-04-09
Summary:summary

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