The following data is part of a premarket notification filed by Kuraray Medical Inc. with the FDA for Panavia F 2.0.
| Device ID | K032455 |
| 510k Number | K032455 |
| Device Name: | PANAVIA F 2.0 |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-08-11 |
| Decision Date | 2003-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR000497KA1 | K032455 | 000 |
| EKUR000481KA1 | K032455 | 000 |
| EKUR000482KA1 | K032455 | 000 |
| EKUR000483KA1 | K032455 | 000 |
| EKUR000490KA1 | K032455 | 000 |
| EKUR000491KA1 | K032455 | 000 |
| EKUR000492KA1 | K032455 | 000 |
| EKUR000493KA1 | K032455 | 000 |
| EKUR000494KA1 | K032455 | 000 |
| EKUR000495KA1 | K032455 | 000 |
| EKUR000496KA1 | K032455 | 000 |
| EKUR000480KA1 | K032455 | 000 |