Rainbow LS Pressing

Powder, Porcelain

GENOSS

The following data is part of a premarket notification filed by Genoss with the FDA for Rainbow Ls Pressing.

Pre-market Notification Details

Device IDK151846
510k NumberK151846
Device Name:Rainbow LS Pressing
ClassificationPowder, Porcelain
Applicant GENOSS 1F, GYEONGGI R&DB CENTER / 226, 2F, GSBC Suwon-si,  KR 443-270
ContactByungsun Kim
CorrespondentDachan Kwon
iCT America, Inc. 180 Sylvan Ave., 2nd Floor Englewood Cliffs,  NJ  07632
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-07
Decision Date2016-01-14
Summary:summary

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