The following data is part of a premarket notification filed by Noritake Co., Inc. with the FDA for Super Porcelain Ti-22.
Device ID | K992024 |
510k Number | K992024 |
Device Name: | SUPER PORCELAIN TI-22 |
Classification | Powder, Porcelain |
Applicant | NORITAKE CO., INC. 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 -5339 |
Contact | Marsha C Wertzberger |
Correspondent | Marsha C Wertzberger NORITAKE CO., INC. 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 -5339 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-16 |
Decision Date | 1999-08-27 |