TRI-PHASIX CHROMATIC ALGINATE

Material, Impression

PARKELL, INC.

The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Tri-phasix Chromatic Alginate.

Pre-market Notification Details

Device IDK962741
510k NumberK962741
Device Name:TRI-PHASIX CHROMATIC ALGINATE
ClassificationMaterial, Impression
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 CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-15
Decision Date1996-09-06
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.