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 |