The following data is part of a premarket notification filed by Arent, Fox, Kintner, Plotkin & Kahn with the FDA for Cimpat N.
| Device ID | K972485 |
| 510k Number | K972485 |
| Device Name: | CIMPAT N |
| Classification | Cement, Dental |
| Applicant | ARENT, FOX, KINTNER, PLOTKIN & KAHN 1050 CONNECTICUT AVE., N.W. Washington, DC 20036 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz ARENT, FOX, KINTNER, PLOTKIN & KAHN 1050 CONNECTICUT AVE., N.W. Washington, DC 20036 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-02 |
| Decision Date | 1997-09-08 |