The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Epricord.
| Device ID | K033267 |
| 510k Number | K033267 |
| Device Name: | EPRICORD |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KURARAY MEDICAL INC. 101 EAST 52ND STREET, 26TH FL. New York, NY 10022 |
| Contact | Satoshi Yamaguchi |
| Correspondent | Satoshi Yamaguchi KURARAY MEDICAL INC. 101 EAST 52ND STREET, 26TH FL. New York, NY 10022 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-09 |
| Decision Date | 2003-12-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EPRICORD 76145257 2689849 Dead/Cancelled |
KURARAY CO., LTD. 2000-10-11 |