The following data is part of a premarket notification filed by Genoss with the FDA for Rainbow Ls Pressing.
Device ID | K151846 |
510k Number | K151846 |
Device Name: | Rainbow LS Pressing |
Classification | Powder, Porcelain |
Applicant | GENOSS 1F, GYEONGGI R&DB CENTER / 226, 2F, GSBC Suwon-si, KR 443-270 |
Contact | Byungsun Kim |
Correspondent | Dachan Kwon iCT America, Inc. 180 Sylvan Ave., 2nd Floor Englewood Cliffs, NJ 07632 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-07 |
Decision Date | 2016-01-14 |
Summary: | summary |