The following data is part of a premarket notification filed by Williams Gold Refining Co., Inc. with the FDA for Renaissance Bonding Agent.
| Device ID | K844394 |
| 510k Number | K844394 |
| Device Name: | RENAISSANCE BONDING AGENT |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | WILLIAMS GOLD REFINING CO., INC. 2978 MAIN ST. Buffalo, NY 14214 |
| Contact | Lawrence A Williams |
| Correspondent | Lawrence A Williams WILLIAMS GOLD REFINING CO., INC. 2978 MAIN ST. Buffalo, NY 14214 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-13 |
| Decision Date | 1985-01-09 |