The following data is part of a premarket notification filed by Noritake Co., Inc. with the FDA for Super Porcelain Addmate.
| Device ID | K983247 |
| 510k Number | K983247 |
| Device Name: | SUPER PORCELAIN ADDMATE |
| 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 | 1998-09-16 |
| Decision Date | 1998-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR1020250KA0 | K983247 | 000 |
| EKUR1260131KA0 | K983247 | 000 |
| EKUR1023951KA0 | K983247 | 000 |
| EKUR1023941KA0 | K983247 | 000 |
| EKUR1023931KA0 | K983247 | 000 |
| EKUR1023921KA0 | K983247 | 000 |
| EKUR1023911KA0 | K983247 | 000 |
| EKUR1023901KA0 | K983247 | 000 |
| EKUR1023891KA0 | K983247 | 000 |