The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Surgi Pak Ne And Cocoment Eugenal Free Paste Syst.
| Device ID | K902817 |
| 510k Number | K902817 |
| Device Name: | SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST |
| Classification | Cement, Dental |
| Applicant | CONFI-DENTAL PRODUCTS CO. 385 S. PIERCE AVE. COLORADO TECH CENTER Louisville, CO 80027 -3017 |
| Contact | Brahma D Sharma |
| Correspondent | Brahma D Sharma CONFI-DENTAL PRODUCTS CO. 385 S. PIERCE AVE. COLORADO TECH CENTER Louisville, CO 80027 -3017 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-27 |
| Decision Date | 1990-08-28 |