The following data is part of a premarket notification filed by Noritake Co., Inc. with the FDA for Super Porcelain Ex-3 Press.
Device ID | K052304 |
510k Number | K052304 |
Device Name: | SUPER PORCELAIN EX-3 PRESS |
Classification | Powder, Porcelain |
Applicant | NORITAKE CO., INC. 3050 K STREET, NW, STE 400 Washington, DC 20007 |
Contact | Ivan J Wasserman |
Correspondent | Ivan J Wasserman NORITAKE CO., INC. 3050 K STREET, NW, STE 400 Washington, DC 20007 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-08-24 |
Decision Date | 2005-11-23 |