The following data is part of a premarket notification filed by Genoss Co., Ltd. with the FDA for Rainbow Block.
Device ID | K092513 |
510k Number | K092513 |
Device Name: | RAINBOW BLOCK |
Classification | Powder, Porcelain |
Applicant | GENOSS CO., LTD. 11075 KNOTT AVE., SUITE A Cypress, CA 90630 |
Contact | Eunkyung Son |
Correspondent | Eunkyung Son GENOSS CO., LTD. 11075 KNOTT AVE., SUITE A Cypress, CA 90630 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-08-17 |
Decision Date | 2009-10-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08809324768441 | K092513 | 000 |
08809324768434 | K092513 | 000 |
08809324768427 | K092513 | 000 |
08809324768410 | K092513 | 000 |
08809324768403 | K092513 | 000 |
08809324768397 | K092513 | 000 |
08809324768380 | K092513 | 000 |