The following data is part of a premarket notification filed by North American Alloys, Inc. with the FDA for Alloy B.
| Device ID | K853845 |
| 510k Number | K853845 |
| Device Name: | ALLOY B |
| Classification | Alloy, Metal, Base |
| Applicant | NORTH AMERICAN ALLOYS, INC. 225 BRENTWOOD CT. Bloomingdale, IL 60108 |
| Contact | Manny Calero |
| Correspondent | Manny Calero NORTH AMERICAN ALLOYS, INC. 225 BRENTWOOD CT. Bloomingdale, IL 60108 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-16 |
| Decision Date | 1985-11-19 |