The following data is part of a premarket notification filed by Aurex Precious Metal Industries (pty)ltd with the FDA for Hipallaur 19.
| Device ID | K972950 |
| 510k Number | K972950 |
| Device Name: | HIPALLAUR 19 |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD P.O. BOX 509 Edenvale, ZA 1610 |
| Contact | J.d. Davis |
| Correspondent | J.d. Davis AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD P.O. BOX 509 Edenvale, ZA 1610 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-20 |
| Decision Date | 1997-09-05 |
| Summary: | summary |